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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceJEWEL AF SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980050
Supplement NumberS001
Date Received06/15/2000
Decision Date04/06/2001
Product Code LWS 
Docket Number 01M-0254
Notice Date 06/06/2001
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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