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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.
 
Trade NameMEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber implantable cdardioverter defibrillator system
Applicant MEDTRONIC INC.
PMA NumberP980050
Date Received12/24/1998
Decision Date06/14/2000
Product Code
LWS[ Registered Establishments with LWS ]
Docket Number 00M-1389
Notice Date 07/12/2000
Advisory Committee Cardiovascular
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) jewel(r) af 7250 dual chamber implantable cardioverter defibrillator (icd), model 9961 programmer application software, and medtronic(r) sprint(tm) model 6943 steroid eluting, screw-in, atrial/ventricular lead. This system is indicated for use in icd patients either with atrial tachyarrhythmias or who are at significant risk of developing atrial tachyarrhythmias. Patients indicated for an icd are those patients who are at risk of sudden death due to ventricular.
Approval Order Approval Order
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