76 FR 106 pgs. 31965-31966 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 76Number: 106Pages: 31965 - 31966
Docket number: [Docket Nos. FDA-2011-M-0034, FDA-2011-M-0040, FDA-2011-M-0041, FDA-2011-M-0039, FDA-2011-M-0035, FDA-2011-M-0056, FDA-2011-M-0105, FDA-2011-M-0131, FDA-2011-M-0132, FDA-2011-M-0170, FDA-2011-M-0175, and FDA-2011-M-0198]
FR document: [FR Doc. 2011-13692 Filed 6-1-11; 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-2011-M-0034, FDA-2011-M-0040, FDA-2011-M-0041, FDA-2011-M-0039, FDA-2011-M-0035, FDA-2011-M-0056, FDA-2011-M-0105, FDA-2011-M-0131, FDA-2011-M-0132, FDA-2011-M-0170, FDA-2011-M-0175, and FDA-2011-M-0198]
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 the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that amended 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register . Instead, the Agency now posts this information on the Internet on FDA's home page at http://www.fda.gov.
In accordance with section 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 January 1, 2011, through March 31, 2011. 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 |
|---|---|---|---|
| P010012 (S230) | Boston Scientific Corp | BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS | September 16, 2010. |
| FDA-2011-M-0034 | |||
| P100021 | Medtronic Vascular | MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM | December 16, 2010. |
| FDA-2011-M-0040 | |||
| P100010 | Medtronic Cryocath, LP | ARCTIC FRONT CRYOCATHETER SYSTEM | December 17, 2010. |
| FDA-2011-M-0041 | |||
| P070014 (S10) | Bard Peripheral Vascular | LIFESTENT AND LIFESTENT LX VASCULAR STENT SYSTEMS | December 23, 2010. |
| FDA-2011-M-0039 | |||
| P070026 | Depuy, Inc | CERAMAX CERAMIC HIP SYSTEM | December 23, 2010. |
| FDA-2011-M-0035 | |||
| P100028 | Cook Medical, Inc | FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM | January 14, 2011. |
| FDA-2011-M-0056 | |||
| P090013 | Medtronic, Inc | REVO MRI SURESCAN IPG AND PACING SYSTEM | February 8, 2011. |
| FDA-2011-M-0105 | |||
| P080003 | Hologic, Inc | SELENIA DIMENSIONS 3D SYSTEMS | February 11, 2011. |
| FDA2011-M-0131 | |||
| P080027 (S1) | OraSure Technologies, Inc | ORAQUICK HCV RAPID ANTIBODY TEST | February 18, 2011. |
| FDA-2011-M-0132 | |||
| H080005 | Elana, Inc | ELANA SURGICAL KIT HUD | March 10, 2011. |
| FDA-2011-M-0170 | |||
| P080025 | Medtronic Neuromodulation | MEDTRONIC INTERSTIM THERAPY SYSTEM | March 14, 2011. |
| FDA-2011-M-0175 | |||
| P80020 | Seikagaku Corp | GEL-ONE | March 22, 2011. |
| FDA-2011-M-0198 |
II. Electronic Access
Persons with access to the Internet may obtain the documents at http://www.fda.gov/cdrh/pmapage.html .
Dated: May 27, 2011.
Nancy K. Stade,
Deputy Director for Policy Center for Devices and Radiological Health.
[FR Doc. 2011-13692 Filed 6-1-11; 8:45 am]
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