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. |
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Device | INSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289 |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S010 |
Date Received | 10/06/2003 |
Decision Date | 10/23/2003 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR BATTERY CHANGES TO THE CHI 4420L BATTERY IN THE MEDTRONIC MARQUIS DR MODEL 7274, MARQUIS VR MODEL 7230, MAXIMO DR MODEL 7278, MAXIMO VR MODEL 7232, INSYNC MARQUIS MODEL 7277 AND THE INSYNC II MARQUIS MODEL 7289. |
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