Notices. Notice
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/register/2011/06/02/2011-13692A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4184-01-P 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. Table 1—List of Safety and Effectiveness Summaries for Approved PMAs Made Available From January 1, 2011, Through March 31, 2011 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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