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 | PARADYM ICDS AND CRT-D DEVICES |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P060027 |
Supplement Number | S029 |
Date Received | 12/16/2010 |
Decision Date | 02/10/2011 |
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 THE CHANGES OF THE TRANSFORMER (T413), OPTO WEDGE (G309), AND DESICCANT (J907) FOR THE PARADYM ICD AND CRT-D MODELS 8250, 8550, AND 8750. |
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