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Device | MEDTRONIC GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P900061 |
Supplement Number | S036 |
Date Received | 03/08/1999 |
Decision Date | 12/02/1999 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Medtronic(R) Model 7227 GEM(TM) Implantable Cardioverter Defibrillator with Connector Configuration Modules 5227B, 5227D, and 5227E. |