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 | REPLY SR, REPLY DR, ESPIRIT SR, ESPRIT DR |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S097 |
Date Received | 10/01/2014 |
Decision Date | 10/23/2014 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE IMPLANT MANUALS IN ALIGNMENT WITH A PREVIOUS SAFETY COMMUNICATION. |
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