78 FR 55 pgs. 17415-17416 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 78Number: 55Pages: 17415 - 17416
Docket number: [Docket Nos. FDA-2012-M-1012, FDA-2012-M-1039, FDA-2012-M-1048, FDA-2012-M-1049, FDA-2012-M-1066, FDA-2012-M-1084, FDA-2012-M-1085, FDA-2012-M-1088, FDA-2012-M-1109, FDA-2012-M-1110, FDA-2012-M-1111, FDA-2012-M-1146, FDA-2012-M-1176, FDA-2012-M-1183, and FDA-2012-M-1184]
FR document: [FR Doc. 2013-06429 Filed 3-20-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2012-M-1012, FDA-2012-M-1039, FDA-2012-M-1048, FDA-2012-M-1049, FDA-2012-M-1066, FDA-2012-M-1084, FDA-2012-M-1085, FDA-2012-M-1088, FDA-2012-M-1109, FDA-2012-M-1110, FDA-2012-M-1111, FDA-2012-M-1146, FDA-2012-M-1176, FDA-2012-M-1183, and FDA-2012-M-1184]
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) is publishing a list of premarket approval applications (PMAs) that have been approved. 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 Division of Dockets Management.
ADDRESSES:
Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness.
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002,301-796-6570.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the 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 placed on the Internet. 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.
The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from October 1, 2012, through December 31, 2012. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date.
| PMA No., Docket No. | Applicant | Trade name | Approval date |
|---|---|---|---|
| P110038, FDA-2012-M-1012 | Bolton Medical Inc | Relay® Thoracic Stent-Graft with Plus Delivery System | September 21, 2012. |
| P110042, FDA-2012-M-1048 | Cameron Health, Inc | Subcutaneous Implantable Defibrillator (S-ICD®) System | September 28, 2012. |
| P100003, FDA-2012-M-1039 | Globus Medical, Inc | Secure-C Artificial Cervical Disc | September 28, 2012. |
| P120005, FDA-2012-M-1049 | Dexcom, Inc | Dexcom G4 PLATINUM Continuous Glucose Monitoring System | October 5, 2012. |
| P120006, FDA-2012-M-1110 | TriVascular, Inc | Ovation Abdominal Stent Graft System | October 5, 2012. |
| P120007, FDA-2012-M-1066 | Gen-Probe, Inc | APTIMA® HPV 16 18/45 Genotype Assay | October 12, 2012. |
| P110008, FDA-2012-M-1085 | Paradigm Spine, LLC | coflex® Interlaminar Technology | October 17, 2012. |
| P110039, FDA-2012-M-1084 | InSightec, Inc | InSightec ExAblate® System | October 18, 2012. |
| P110021, FDA-2012-M-1088 | Edwards Lifesciences, LLC | Edwards SAPIEN TM Transcatheter Heart Valve | October 19, 2012. |
| P100040/S008, FDA-2012-M-1109 | Medtronic Vascular | Valiant® Thoracic Stent Graft with the Captivia Delivery System | October 26, 2012. |
| P100012, FDA-2012-M-1111 | NuVasive, Inc | PCM® Cervical Disc System | October 26, 2012. |
| P120002, FDA-2012-M-1183 | Cordis Corporation | S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent Systems. | November 7, 2012 |
| P100022, FDA-2012-M-1146 | Cook, Inc | Zilver PTX Drug-Eluting Peripheral Stent | November 14, 2012. |
| P100047, FDA-2012-M-1184 | HeartWare, Inc | HeartWare® Ventricular Assist System | November 20, 2012. |
| P120008, FDA-2012-M-1176 | Abbott Laboratories | ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls | November 28, 2012. |
II. Electronic Access
Persons with access to the Internet may obtain the documents at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
Dated: March 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06429 Filed 3-20-13; 8:45 am]
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