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, INSYNC II, MARQUIS MODEL 7289, INSYNC III MARQUIS MODEL 7279, INSYNC II PROTECT MODEL 7295 |
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 | S042 |
Date Received | 06/02/2006 |
Decision Date | 07/26/2006 |
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 |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE HIGH VOLTAGE CAPACITOR LINER USER IN THE REFERENCED DEFIBRILLATORS. |
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