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Food and Drug Administration

[Docket Nos. FDA-2008-M-0207, FDA-2008-M-0243, FDA-2008-M-0244, FDA-2008-M-0283, FDA-2008-M-0335, FDA-2008-M-0311, FDA-2008-M-0342, FDA-2008-M-0378]

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 theSUPPLEMENTARY INFORMATIONsection for electronic access to the summaries of safety and effectiveness.
FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4010.
SUPPLEMENTARY INFORMATION: I. Background

In theFederal Registerof January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in theFederal Register. Instead, the agency now posts this information on the Internet on FDA's home page athttp://www.fda.gov. FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in theFederal Register, and FDA believes that the Internet is accessible to more people than theFederal Register.

In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, andCosmetic Act (the 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 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 April 1, 2008, through June 30, 2008. 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 April 1, 2008, through June 30, 2008 PMA No./Docket No. Applicant TRADE NAME Approval Date P050020
  • FDA-2008-M-0207
  • Abbott Diabetes Care, Inc. FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM March 12, 2008
    P010012 (S037)
  • FDA-2008-M-0243
  • Guidant Corp. Contak Renewal 3 AVT system & contak reviewal 3AVT HE System March 13, 2008
    P070027
  • FDA-2008-M-0244
  • Medtronic Vascular The talent abdominal stent graft system April 15, 2008
    P060040
  • FDA-2008-M-0283
  • Thoratec Corp. Thoratec Heartmate II Left ventricular assist April 21, 2008
    P070008
  • FDA-2008-M-0335
  • Biotronik, Inc. Stratos LV CRT-P & stratos LV-T CRT-P, corox OTW BP lead & corox OTW-s bp lead May 12, 2008
    P070016
  • FDA-2008-M-0311
  • Cook, Inc. Zenith TX2 Thoracic TAA endovascular graft with the H&LB One-shot introduction system May 21, 2008
    P070007
  • FDA-2008-M-0342
  • Medtronic Vascular Talent Thoracic Stent Graft System June 5, 2008
    H070003
  • FDA-2008-M-0378
  • Synapse Biomedical, Inc. NeuRx RA/4 June 17, 2008
    II. Electronic Access

    Persons with access to the Internet may obtain the documents athttp://www.fda.gov/cdrh/pmapage.html.

    Dated: September 12, 2008. Daniel G. Schultz, Director, Center for Devices and Radiological Health.