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 CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM RF CRT-D9750 (ZL102), INTENSIA CRT-D 174 |
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 | S078 |
Date Received | 07/07/2015 |
Decision Date | 07/31/2015 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement OPTIMIZATION OF CLEANING PROCESS AND SUBSEQUENT REMOVAL OF PRIMER BEFORE GLUING STEPS. |
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