87 FR 110 pgs. 34884-34887 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 87Number: 110Pages: 34884 - 34887
Pages: 34884, 34885, 34886Docket number: [Docket Nos. FDA-2021-M-0228, FDA-2021-M-0202, FDA-2021-M-0203, FDA-2021-M-0178, FDA-2021-M-0153, FDA-2021-M-0135, FDA-2021-M-0325, FDA-2021-M-0303, FDA-2021-M-0288, FDA-2021-M-0421, FDA-2021-M-0416, FDA-2021-M-0355, FDA-2021-M-0354, FDA-2021-M-0520, FDA-2021-M-0615, FDA-2021-M-0531, FDA-2021-M-0527, FDA-2021-M-0820, FDA-2021-M-0769, FDA-2021-M-0766, FDA-2021-M-0676, FDA-2021-M-0690, FDA-2021-M-0656, FDA-2021-M-0494, FDA-2021-M-0915, FDA-2021-M-0911, FDA-2021-M-0853, FDA-2021-M-0805, FDA-2021-M-1046, FDA-2021-M-1010, FDA-2021-M-0991, FDA-2021-M-0989, FDA-2021-M-0975, FDA-2021-M-0962, FDA-2021-M-1176, FDA-2021-M-1119, FDA-2021-M-1116, FDA-2021-M-0532, FDA-2021-M-1058, FDA-2021-M-1182, FDA-2021-M-1023, FDA-2021-M-1207, FDA-2021-M-1284, FDA-2021-M-1271, FDA-2021-M-1317, FDA-2021-M-1321, FDA-2021-M-1316, FDA-2021-M-1325, FDA-2021-M-1352, FDA-2022-M-0029, FDA-2022-M-0071, FDA-2022-M-0087, FDA-2022-M-0089, FDA-2022-M-0090, and FDA-2022-M-0171].
FR document: [FR Doc. 2022-12371 Filed 6-7-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2021-M-0228, FDA-2021-M-0202, FDA-2021-M-0203, FDA-2021-M-0178, FDA-2021-M-0153, FDA-2021-M-0135, FDA-2021-M-0325, FDA-2021-M-0303, FDA-2021-M-0288, FDA-2021-M-0421, FDA-2021-M-0416, FDA-2021-M-0355, FDA-2021-M-0354, FDA-2021-M-0520, FDA-2021-M-0615, FDA-2021-M-0531, FDA-2021-M-0527, FDA-2021-M-0820, FDA-2021-M-0769, FDA-2021-M-0766, FDA-2021-M-0676, FDA-2021-M-0690, FDA-2021-M-0656, FDA-2021-M-0494, FDA-2021-M-0915, FDA-2021-M-0911, FDA-2021-M-0853, FDA-2021-M-0805, FDA-2021-M-1046, FDA-2021-M-1010, FDA-2021-M-0991, FDA-2021-M-0989, FDA-2021-M-0975, FDA-2021-M-0962, FDA-2021-M-1176, FDA-2021-M-1119, FDA-2021-M-1116, FDA-2021-M-0532, FDA-2021-M-1058, FDA-2021-M-1182, FDA-2021-M-1023, FDA-2021-M-1207, FDA-2021-M-1284, FDA-2021-M-1271, FDA-2021-M-1317, FDA-2021-M-1321, FDA-2021-M-1316, FDA-2021-M-1325, FDA-2021-M-1352, FDA-2022-M-0029, FDA-2022-M-0071, FDA-2022-M-0087, FDA-2022-M-0089, FDA-2022-M-0090, and FDA-2022-M-0171].
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved from January 1, 2021, through February 14, 2022. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff. This is the last notice of this kind considering FDA's rule discontinuing the practice of publishing such summaries in the Federal Register . As indicated in that rule, FDA will continue to publish to make available on the internet and place on public display summaries of safety and effectiveness for approved PMAs.
ADDRESSES:
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").
Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."
[top] Instructions: All submissions received must include the Docket Nos. FDA-2021-M-0228, FDA-2021-M-0202, FDA-2021-M-0203, FDA-2021-M-0178, FDA-2021-M-0153, FDA-2021-M-0135, FDA-2021-M-0325, FDA-2021-M-0303, FDA-2021-M-0288, FDA-2021-M-0421, FDA-2021-M-0416, FDA-2021-M-0355, FDA-2021-M-0354, FDA-2021-M-0520, FDA-2021-M-0615, FDA-2021-M-0531, FDA-2021-M-0527, FDA-2021-M-0820, FDA-2021-M-0769, FDA-2021-M-0766, FDA-2021-M-0676, FDA-
• Confidential Submissions-To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT:
Dharmesh Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2434, Silver Spring, MD 20993-0002, 301-796-3289, Dharmesh.Patel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the FD&C Act. The 30-day period for requesting reconsideration of an FDA action under §?10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is published in the Federal Register . Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision.
Prior to February 14, 2022, the regulations provided that FDA publish a list of available safety and effectiveness summaries of PMA approvals and denials that were announced in the Federal Register . FDA issued a rule discontinuing this practice on January 13, 2022 (87 FR 2042). At that time, FDA committed to continue to publish lists of safety and effectiveness summaries of PMA approvals and denials on its website. The following list of approved PMAs for which summaries of safety and effectiveness that were placed on the internet from January 1, 2021, through February 14, 2022, will, therefore, be our last such list to be published in this manner. There were no denial actions during this period. The list in table 1 provides the manufacturer's name, the product's generic name or trade name, and the approval date.
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| PMA No., docket No. | Applicant | Trade name | Approval date |
|---|---|---|---|
| P200003, FDA-2021-M-0070 | Seno Medical Instruments, Inc | Imagio® Breast Imaging System | 1/11/21 |
| P200028, FDA-2021-M-0135 | Medtronic, Inc | DiamondTemp TM Ablation System consisting of DiamondTemp TM AblaDiamondTemp Ablation Catheter (Models CEDT100S, CEDT200L, CEDTB300S, CEDTB400L); DiamondTemp TM RF Generator (Model CEDTG200); DiamondTemp TM Irrigation Pump (Model CEDTP100); DiamondTemp TM Irrigation Tubing Set (Model CEDTTS100); DiamondTemp TM Catheter-to-RF Generator Cable (Model CEDTC100); DiamondTemp TM GenConnect Cable (Model CEDTGC100); DiamondTemp TM EGM Cable (Model CEDTEGM100) | 1/28/2021 |
| P140029/S027, FDA-2021-M-0153 | Q-Med AB | Restylane® Defyne | 1/29/2021 |
| P190005, FDA-2021-M-0178 | Roche Diagnostics | Elecsys Anti-HBe, PreciControl Anti-HBe | 2/3/2021 |
| P200039, FDA-2021-M-0202 | Shockwave Medical, Inc | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C 2 Coronary Intravascular Lithotripsy (IVL) Catheter | 2/12/2021 |
| P190013, FDA-2021-M-0288 | AED Battery Exchange, LLC | AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) | 2/13/2021 |
| H200001, FDA-2021-M-0203 | Additive Orthopaedics, LLC | Patient Specific Talus Spacer | 2/17/2021 |
| P190034, FDA-2021-M-0228 | Roche Diagnostics | Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck | 2/23/2021 |
| P200029, FDA-2021-M-0303 | Boston Scientific Corporation | TheraSphere TM | 3/17/2021 |
| P200025, FDA-2021-M-0325 | Bausch Health | ClearVisc Ophthalmic Viscosurgical Device (OVD) | 3/23/2021 |
| P200046, FDA-2021-M-0354 | Medtronic, Inc | Medtronic Harmony Transcatheter Pulmonary Valve (TPV) System | 3/26/2021 |
| P200022/S003, FDA-2021-M-0355 | Simplify Medical, Inc | Simplify® Cervical Artificial Disc | 4/1/2021 |
| P200019, FDA-2021-M-0416 | Ventana Medical Systems, Inc | VENTANA MMR RxDx Panel | 4/22/2021 |
| P980040/S124, FDA-2021-M-0421 | Johnson & Johnson Surgical Vision, Inc | TECNIS Synergy TM IOL, Model ZFR00V, TECNIS Synergy TM Toric II IOL, Models ZFW150, ZFW225, ZFW300, ZFW375, TECNIS Synergy TM IOL with TECNIS Simplicity TM Delivery System, Model DFR00V, TECNIS Synergy TM Toric II IOL with TECNIS Simplicity TM Delivery System, Model DFW150, DFW225, DFW300, DFW375 | 4/28/2021 |
| P200002, FDA-2021-M-0418 | AtriCure, Inc | EPi-Sense® Guided Coagulation System | 4/28/21 |
| P140031/S125, FDA-2021-M-0473 | Edwards Lifesciences, LLC | Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System | 5/13/21 |
| P200010/S001, FDA-2021-M-0520 | Guardant Health, Inc | Guardant360 CDx | 5/21/2021 |
| P110027/S012, FDA-2021-M-0531 | QIAGEN GmbH | therascreen® KRAS RGQ PCR Kit | 5/28/2021 |
| P110033/S053, FDA-2021-M-0527 | Allergan | JUVÉDERM® VOLBELLA® XC | 5/28/2021 |
| P200010/S002, FDA-2021-M-0494 | Guardant Health, Inc | Guardant360 CDx | 5/28/2021 |
| P100010/S110, FDA-2021-M-0690 | Medtronic, Inc | Arctic Front AdvanceTM Cardiac Cryoablation Catheters, Arctic Front Advance ProTM Cardiac Cryoablation Catheters, FreezorTM MAX Cardiac Cryoablation Catheter, CryoConsole Manual Retraction Kit | 6/18/2021 |
| P200021, FDA-2021-M-0615 | Oticon Medical | Neuro Cochlear Implant System | 6/23/2021 |
| P110019/S115, FDA-2021-M-0656 | Abbott Vascular | XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Stent Systems (XIENCE Sierra EECSS), and the XIENCE Skypoint Everolimus Eluting Coronary Stent Systems (XIENCE Skypoint EECSS) | 6/25/2021 |
| P140029/S032, FDA-2021-M-0676 | Q-Med AB, a Galderma affiliate | Restylane® Contour | 6/28/2021 |
| P200017, FDA-2021-M-0766 | Siemens Healthcare Diagnostics Inc | ADVIA Centaur® Anti-HBe2 (aHBe2) assay | 7/14/2021 |
| P190032/S001, FDA-2021-M-0707 | Foundation Medical, Inc | FoundationOne® Liquid CDx (F1 Liquid) | 7/15/21 |
| P130022/S039, FDA-2021-M-0769 | Nervo Corporation | Senza® Spinal Cord Stimulation (SCS) System | 7/16/2021 |
| P200037, FDA-2021-M-0820 | Kestra Medical Technologies, Inc | ASSURE® Wearable Cardioverter Defibrillator (WCD) System (ASSURE System) | 7/27/2021 |
| P200011, FDA-2021-M-0853 | Pillar Biosciences, Inc | ONCO/Reveal TM Dx Lung & Colon Cancer Assay | 7/30/2021 |
| P200045, FDA-2021-M-0805 | Bolton Medical, Inc | RelayPro Thoracic Stent-Graft System | 8/5/2021 |
| P200049, FDA-2021-M-0911 | Abbott Medical | Amplatzer TM Amulet TM Left Atrial Appendage Occluder | 8/14/2021 |
| P210001, FDA-2021-M-0915 | Ventana Medical Systems, Inc | VENTANA MMR RxDx Panel | 8/17/2021 |
| P160045/S028, FDA-2021-M-0962 | Life Technologies Corporation | Oncomine® Dx Target Test | 8/25/2021 |
| P210007, FDA-2021-M-0991 | MicroTransponder Inc | MicroTransponder® Vivistim® Paired VNS TM System (Vivistim® System) | 8/27/2021 |
| P050052/S129, FDA-2021-M-0975 | Merz North America, Inc | RADIESSE® (+) Lidocaine injectable implant | 9/1/2021 |
| P180051, FDA-2021-M-0989 | TransMedics, Inc | Organ Care System (OCS TM ) Heart System | 9/3/2021 |
| P160045/S029, FDA-2021-M-1023 | Life Technologies Corporation | Oncomine TM Dx Target Test | 9/15/2021 |
| P190023, FDA-2021-M-1010 | Abbott Medical | Portico TM Transcatheter Aortic Valve Implantation System: Portico TM Transcatheter Aortic Heart Valve, FlexNav TM Delivery System, FlexNav TM Loading System | 9/17/2021 |
| P200004, FDA-2021-M-1046 | ConMed Corporation | ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters | 9/26/2021 |
| P200031, FDA-2021-M-1058 | TransMedics, Inc | Organ Care System (OCS TM ) Liver | 9/28/2021 |
| P210026, FDA-2021-M-1116 | Agilent Technologies, Inc | Ki-67 IHC MIB-1 pharmDx (Dako Omnis) | 10/12/2021 |
| P190012, FDA-2021-M-1119 | Spatz FGIA Inc | Spatz3 Adjustable Balloon System | 10/15/2021 |
| P160046/S010, FDA-2021-M-0532 | Ventana Medical Systems, Inc | VENTANA PD-L1 (SP263) Assay | 10/15/2021 |
| P150031/S040, FDA-2021-M-1176 | Boston Scientific Corporation | Vercise PC, Vercise Gevia and Vercise Genus DBS Systems | 10/20/2021 |
| P150038/S014, FDA-2021-M-1182 | INSIGHTEC, Inc | Exablate Model 4000 Type 1.0 and 1.1 System ("Exablate Neuro") | 10/29/21 |
| P130026/S070, FDA-2021-M-1207 | Abbott Medical | TactiCath Contact Force Ablation Catheter, Sensor Enabled (Uni-Directional); TactiCath Contact Force Ablation Catheter, Sensor Enabled (Bi-Directional); TactiSys Quartz Equipment; Ampere RF Generator and Cool Point Irrigation Pump | 11/4/21 |
| P210020, FDA-2021-M-1284 | Urotronic, Inc | Optilume® Urethral Drug Coated Balloon | 12/3/21 |
| P190022, FDA-2021-M-1271 | OPKO Health, Inc | 4Kscore® Test | 12/7/21 |
| P200035, FDA-2021-M-1317 | OrganOx Limited | OrganOx metra® System | 12/9/21 |
| P210014, FDA-2021-M-1321 | Svelte Medical Systems, Inc | SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System | 12/13/21 |
| P200041, FDA-2021-M-1316 | OrbusNeich Medical (Shenzhen) Co., Ltd | Scoreflex NC Scoring PTCA Catheter | 12/21/21 |
| P200015/S011, FDA-2021-M-1325 | Edwards Lifesciences LLC | Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent | 12/16/21 |
| P200040, FDA-2021-M-1352 | Delphinus Medical Technologies, Inc | SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly | 10/6/21 |
| P170002/S012, FDA-2022-M-0029 | TEOXANE S.A | RHA® Redensity TM | 12/22/21 |
| P970051/S205, FDA-2022-M-0071 | Cochlear Americas | Nucleus 24 Cochlear Implant System | 1/10/22 |
| P130022/S042, FDA-2022-M-0087 | Nevro Corporation | Senza® Spinal Cord Stimulation (SCS) System | 1/18/22 |
| P840001/S469, FDA-2022-M-089 | Medtronic Neuromodulation | Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord Stimulation Systems, Pisces, Specify and Vectris Spinal Cord Stimulation Leads | 1/21/22 |
| P080012/S068, FDA-2022-M-0090 | Flowonix Medical, Inc | Prometra® Programmable Infusion Pump System | 1/12/22 |
| P160048/S016, FDA-2022-M-0171 | Senseonics, Incorporated | Eversense® E3 Continuous Glucose Monitoring System | 2/10/22 |
II. Electronic Access
Persons with access to the internet may obtain the documents at https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
Dated: June 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12371 Filed 6-7-22; 8:45 am]
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