|
Device | SYMPHONY & ELA RHAPSODY PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S033 |
Date Received | 01/14/2008 |
Decision Date | 02/13/2008 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITION INSPECTION STEP TO WEIGH THE FINAL DEVICE AFTER MANUFACTURING OF THE DEVICES. |