|
Device | SYMPHONY SR/DR & RHAPSODY SR/DR |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S038 |
Date Received | 09/15/2008 |
Decision Date | 10/17/2008 |
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 THE WELDING ENERGY MEASUREMENT METHOD FROM AN INDIRECT METHOD TO A DIRECT ENERGY MEASUREMENT METHOD. |