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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 7278 MAXIMO DR DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND MODEL 7232 MAXIMO VR SINGLE CHAM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980016
Supplement NumberS042
Date Received03/26/2004
Decision Date04/08/2004
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC MEDREL, JUNCOS, PUERTO RICO.
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