|
Device | MEDTRONIC MODEL 7227CX GEM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
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 | S038 |
Date Received | 05/26/1999 |
Decision Date | 06/16/1999 |
Product Code |
LWS |
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. |