DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
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.
Abbott Diabetes Care, Inc.
FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
March 12, 2008
Contak Renewal 3 AVT system & contak reviewal 3AVT HE System
March 13, 2008
The talent abdominal stent graft system
April 15, 2008
Thoratec Heartmate II Left ventricular assist
April 21, 2008
Stratos LV CRT-P & stratos LV-T CRT-P, corox OTW BP lead & corox OTW-s bp lead
May 12, 2008
Zenith TX2 Thoracic TAA endovascular graft with the H&LB One-shot introduction system
May 21, 2008
Talent Thoracic Stent Graft System
June 5, 2008
Synapse Biomedical, Inc.
June 17, 2008
II. Electronic Access