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 | MEDTRONIC CONSULTA CRT-D D204TRM, MAXIMO II CRT-D D264TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
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 | S176 |
Date Received | 12/04/2009 |
Decision Date | 01/09/2012 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE DF4 CONNECTOR SYSTEM, WHICH IS COMPRISED OF THE ICD, CRT-D AND DEFIBRILLATION LEAD DEVICES FOR THE DEVICES. |
Approval Order | Approval Order |
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