[Federal Register Volume 60, Number 77 (Friday, April 21, 1995)]
[Notices]
[Pages 19948-19949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9950]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95M-0072]


Cardiac Pacemakers, Inc., Premarket Approval of VENTAK<Register> 
P2 AICD<SUP>TM System: Model 1625 VENTAK<Register> P2 Pulse Generator, 
Model 2835 Software Module, and Model 2815 VENTAK<Register> ECD 
External Cardioverter Defibrillator

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Cardiac Pacemakers, Inc., St. Paul, MN, 
for premarket approval, under the Federal Food, Drug, and Cosmetic Act 
(the act), of the VENTAK<Register> P2 AICD<SUP>TM System. FDA's Center 
for Devices and Radiological Health (CDRH) notified the applicant, by 
letter of March 10, 1995, of the approval of the application.

DATES: Petitions for administrative review by May 22, 1995.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Carole C. Carey, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8609.

SUPPLEMENTARY INFORMATION: On August 30, 1993, Cardiac Pacemakers, 
Inc., St. Paul, MN 55112, submitted to CDRH an application for 
premarket approval of VENTAK<Register> P2 AICD<SUP>TM System consists 
of the following: Model 1625 VENTAK<Register> P2 pulse generator; Model 
2835 Software Module to be used with commercially available Cardiac 
Pacemakers, Inc., (CPI<Register>) Model 2035 Handheld Programmer and 
Model 6575 or 6577 Telemetry Wand; Model 2815 VENTAK<Register> ECD 
External Cardioverter Defibrillator (which includes the Model 6873 High 
Voltage Cable with Model 6838 Thumbscrew, Model 6843 Bipolar Cable with 
Model 6838 Thumbscrew, Model 6874 Bipolar Cable, and related 
CPI<Register> commercially available accessories); commercially 
available CPI<Register> ENDOTAK<Register> 60-Series Lead System and 
accessories; commercially available CPI<Register> epicardial 
defibrillation leads and accessories; and commercially available pace/
sense leads and accessories. The device is an automatic implantable 
cardioverter defibrillator system and is indicated for the treatment of 
patients with ventricular fibrillation and/or ventricular 
tachyarrhythmias who are at high risk of sudden cardiac death. Such 
patients are defined as having experienced the following situations: 
(1) The survival of at least one episode of cardiac arrest presumably 
due to hemodynamically unstable ventricular tachyarrhythmia not 
associated with acute myocardial infarction, and/or (2) a poorly 
tolerated, sustained ventricular tachycardia (VT) and/or ventricular 
fibrillation (VF) which recurs spontaneously or can be induced despite 
the best antiarrhythmic drug therapy. Note: The clinical outcome of 
hemodynamically stable, sustained VT patients is not fully known. A 
study of the safety and effectiveness of the VENTAK<Register> P2 system 
on this selected subgroup of VT patients has not been conducted.
     In accordance with the provisions of section 515(c)(2) of the act 
(21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of 
1990, this [[Page 19949]] premarket approval application (PMA) was not 
referred to the Circulatory System Devices Panel of the Medical Devices 
Advisory Committee, an FDA advisory committee, for review and 
recommendation because the information in the PMA substantially 
duplicates information previously reviewed by this panel. On March 10, 
1995, CDRH approved the application by a letter to the applicant from 
the Director of the Office of Device Evaluation, CDRH.
     A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested person to petition, under section 515(g) of the act, for 
administrative review of CDRH's decision to approve this application. A 
petitioner may request either a formal hearing under part 12 (21 CFR 
part 12) of FDA's administrative practices and procedures regulations 
or a review of the application and CDRH's action by an independent 
advisory committee of experts. A petition is to be in the form of a 
petition for reconsideration under Sec. 10.33(b) (21 CFR 10.33(b)). A 
petitioner shall identify the form of review requested (hearing or 
independent advisory committee) and shall submit with the petition 
supporting data and information showing that there is a genuine and 
substantial issue of material fact for resolution through 
administrative review. After reviewing the petition, FDA will decide 
whether to grant or deny the petition and will publish a notice of its 
decision in the Federal Register. If FDA grants the petition, the 
notice will state the issue to be reviewed, the form of review to be 
used, the persons who may participate in the review, the time and place 
where the review will occur, and other details.
    Petitioners may, at any time on or before May 22, 1995, file with 
the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: April 6, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-9950 Filed 4-20-95; 8:45 am]
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