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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cardioverter defibrillator system
PMA NumberP980016
Date Received05/11/1998
Decision Date10/09/1998
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 98M-0907
Notice Date 12/07/1998
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH Recalls
Approval Order Statement 
Approval for the medtronic(r) model 7271 gem(tm) dr dual chamber implantable cardioverter defibrillator system with mdoel 9960 (gem(tm) dr) application software, medtronic(r) model 6940 capsurefix(r) lead and model 9466 patient magnet. This system is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to ventricular tachyarrhythmia or recurrent, poorly tolerated, sustained ventricular tachycardia. (note: the clinical outcome for hemodynamically stable vt patients is not fully known. Safety and effectiveness studies have not been conducted. ).
Post-Approval StudyShow Report Schedule and Study Progress
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