|
Device | SYMPHONY & RHAPSODY SR/REPLY SR/DR/REPLY SR/DR (V2)/ESPRIT SR/DR |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S050 |
Date Received | 01/06/2010 |
Decision Date | 02/05/2010 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE IN LOCATION OF THE HYBRID ELECTRONIC MODULE SUBCOMPONENT MANUFACTURING. |