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Device | MEDTRONIC MODEL 7273 GEM II DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S006 |
Date Received | 05/26/1999 |
Decision Date | 06/16/1999 |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to revise the circuitry of the high power hybrids used in the Model 7227Cx GEM(TM) and the Model 7273 GEM(TM) II DR implantable cardioverter defibrillators to correct the premature low battery problem. |