P060040 - Thoratec Corporation Thoratec HeartMate II® Left Ventricular Assist System (LVAS)

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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

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 at http://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
P050020FDA-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
P070027FDA-2008-M-0244 Medtronic Vascular The talent abdominal stent graft system April 15, 2008
P060040FDA-2008-M-0283 Thoratec Corp. Thoratec Heartmate II Left ventricular assist April 21, 2008
P070008FDA-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
P070016FDA-2008-M-0311 Cook, Inc. Zenith TX2 Thoracic TAA endovascular graft with the HLB One-shot introduction system May 21, 2008
P070007FDA-2008-M-0342 Medtronic Vascular Talent Thoracic Stent Graft System June 5, 2008
H070003FDA-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 at http://www.fda.gov/cdrh/pmapage.html .

Dated: September 12, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-22668 Filed 9-25-08; 8:45 am]
BILLING CODE 4160-01-S
 
Comment Period Closed
ID: FDA-2008-M-0283-0001
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Document Information

Date Posted: Sep 26, 2008
Federal Register Number: E8-22668
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Docket Information

This document is contained in
FDA-2008-M-0283
Related Dockets: None
Related RINs: None
* The total reflects comments received from Regulations.gov and other means as of 11:59 PM yesterday. All comments received may not be posted at this time including bulk submissions; therefore, the total comments received and posted may differ.
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