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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.
 
DeviceMEDTRONIC JEWEL CARDIOVERTER DEFIBRILLATOR
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP900061
Supplement NumberS023
Date Received04/03/1996
Decision Date09/25/1996
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODEL 9895E APPLICATION SOFTWARE, VERSION T6E6V3, FOR MODEL 9790 AND 9790C PROGRAMMERS WHICH PROGRAM THE MODELS 7616/7217, 7201, 7219/02 AND 7220 IMPLANTABLE ARRHYTHMIA MANAGEMENT DEVICES
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