[Federal Register Volume 59, Number 156 (Monday, August 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19924]


[[Page Unknown]]

[Federal Register: August 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0241]

 

Cardiac Pacemakers, Inc., Premarket Approval of VENTAK 
PRx Model 1700 and Model 1705 AICDTM System, Model 2850 
PRESCRIPTORTM Programmer and Model 2860 Program Disk

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 section 515 of the Federal Food, Drug, 
and Cosmetic Act (the act), of the VENTAK PRx Model 
1700 and Model 1705 AICDTM System, Model 2850 PRESCRIPTORTM 
Programmer and Model 2860 Program Disk. After reviewing the 
recommendation of the Circulatory System Devices Panel, FDA's Center 
for Devices and Radiological Health (CDRH) notified the applicant, by 
letter of June 17, 1994, of the approval of the application.

DATES: Petitions for administrative review by September 14, 1994.

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, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-2723.

SUPPLEMENTARY INFORMATION: On December 23, 1991, Cardiac Pacemakers, 
Inc., 4100 Hamline Ave., North, St. Paul, MN 55112, submitted to CDRH 
an application for premarket approval of VENTAK PRx 
Model 1700 and Model 1705 AICDTM System, Model 2850 
PRESCRIPTORTM Programmer and Model 2860 Program Disk. The 
VENTAK PRx Model 1700 and Model 1705 AICDTM 
System, Model 2850 PRESCRIPTORTM Programmer and Model 2860 Program 
Disk consists of the following: Model 1700 or Model 1705 
VENTAK PRx pulse generator; Model 6942 Torque 
Wrench; Models 0065 and 0066 defribrillation patch leads or 
commercially available defribrillation leads; Model 6829 Lead Cap; 
Model 6831 Lead Adapter; Model 6620 Torque Wrench; Model 0011 pace/
sense lead or commercially available pace/sense leads; Model 2850 
PRESCRIPTORTM Programmer; Model 2860 Program Disk (Revision 10); 
Model 6575 or Model 6577 Telemetry Wand; and related programmer 
accessories including Model 6580 Electrogram Cable, Model 6884 BNC-BNC 
Cable, Model 6892 Internal Controller-Stimulator Cable, Model 6896 Ink 
Cartridges, Model 6897 Printer Paper, and Model 6899 Patient Data 
Disks. The device is an automatic implantable cardioverter 
defribrillator 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: 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 poorly tolerated, sustained ventricular 
tachycardia (VT) and/or ventricular fibrillation (VF) which recurs 
spontaneously or can be induced despite the best antiarrhythmic drug 
therapy. (The clinical outcome of hemodynamically stable, sustained VT 
patients is not fully known. A study of the safety and effectiveness of 
the VENTAK PRx system on this selected subgroup of 
VT patients has not been conducted.)
    On August 2, 1993, the Circulatory System Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory committee, reviewed 
and recommended approval of the application. On June 17, 1994, CDRH 
approved the application by a letter to the applicant from the Acting 
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 (21 
U.S.C. 360e(g)), 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 September 14, 1994, 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 Center for Devices and Radiological Health (21 
CFR 5.53).

    Dated: July 29, 1994.
 Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-19924 Filed 8-12-94; 8:45 am]
BILLING CODE 4160-01-F