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 RF VR |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S095 |
Date Received | 03/24/2014 |
Decision Date | 04/16/2014 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES FOR THE DEVICES (PLATFORM ZL102):1) ADDED EQUIPMENT COOLER STACKER/DE-STACKER USED IN THE ELECTRONIC SMD ASSEMBLY LINE;2) LASER WELDING PROCESS REWORK FOR VISUAL DEFECT ON CASE; AND3. PARADYM RF (ZL102), IN SOURCING OF RF MODULE MANUFACTURING |
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