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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 MODEL 7219C/7202C JEWEL ACTIVE CAN MANAGEMENT SYSTEMS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP900061
Supplement NumberS014
Date Received07/03/1995
Decision Date12/06/1995
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 MEDTRONIC MODEL 7219C/7202C JEWEL ACTIVE CAN ARRHYTHMIA MANAGEMENT SYSTEMS. THE MODEL 7220C WAS WITHDRAWN FROM THE REFERENCED APPLICATION, AND THEREFORE APPROVAL IS NOT GRANTED FOR THAT MODEL
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