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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. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantMEDTRONIC Inc.
8200 CORAL SEA STREET
MS MVS11
MOUNDS VIEW, MN 55112
PMA NumberP980050
Supplement NumberS003
Date Received02/05/2001
Decision Date05/25/2001
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE FACILITY FOR THE MANUFACTURING, PACKAGING, AND STERILIZATION OF THE MODEL 7227CX, MODEL 7275, MODEL 7231, AND MODEL 7276 IMPLANTABLE CARDIOVERTER DEFIBRILLATORS LOCATED AT MEDTRONIC S.A., TOLOCHENAZ, SWITZERLAND.
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