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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cdardioverter defibrillator system
PMA NumberP980050
Supplement NumberS001
Date Received06/15/2000
Decision Date04/06/2001
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 01M-0254
Notice Date 06/06/2001
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the medtronic(r) model 7250 jewel(r) af implantable cardioverter defibrillator system, medtronic model 9465 incheck(tm) patients assistant and the medtronic transvene(r) cs/svc model 6937a lead. The system is intended to provide pacing, cardioversion and defibrillation for treatment of patients with symptomatic drug refractory atrial fibrillation and/or life-threatening ventricular tachyarrhythmias.
Approval Order Approval Order