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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 St. N.E
Mounds View, MN 55112
PMA NumberP900061
Supplement NumberS028
Date Received07/15/1996
Decision Date08/06/1996
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE MODEL 7221B/CX/D/E/ MICRO JEWEL WITH ENDOTAK SERIES LEADS INLCUDING 60, 70 AND 110 SERIES LEADS (MODELS 0060, 0062, 0063, 0064, 0070, 0072, 0073, 0074, 0075, 0113, 0115) AND THE MODEL 6836 Y CONNECTOR
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