|
Device | SYMPHONY SR 2250/SYMPHONY DR 2550/RHAPSODY SR 2210/RHAPSODY DR 2510 & 2530 |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S051 |
Date Received | 02/12/2010 |
Decision Date | 03/12/2010 |
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 |
Approval Order Statement CHANGING FROM MANUAL TO AUTOMATED CLEANING PROCESS. |