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 | PACEMAKERS, REPLY SR AND DR, ESPIRIT SR AND DR |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S069 |
Date Received | 07/05/2012 |
Decision Date | 07/30/2012 |
Product Code |
NVZ |
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 MOVED COMPONENT ASSEMBLY STEP, REMOVAL OF AN OPTIONAL CLEANING STEP AND ALTERNATIVE COMPONENT ATTACHMENT INSPECTION EQUIPMENT. |
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