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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 ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP900061
Supplement NumberS029
Date Received11/18/1996
Decision Date03/07/1997
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 JEWEL(R) MODELS 7219 B/D/E, 7202 D/E, 7220 B/D/E, 7221 B/CX/D/E MICROJEWEL(TM), AND 7223 MICRO JEWEL II(TM) WITH ENDOTAK(R) DSP LEAD MODELS 0092, 0093, 0094, 0096, 0097, 0123, AND 0125 AND THE MODEL 6836 Y CONNECTOR.
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