|
Device | REPLY DR/SR & REPLY DR/SR (V2)/ESPRIT DR/SR |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S054 |
Date Received | 07/19/2010 |
Decision Date | 08/18/2010 |
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 ADDING A REINFORCED INSPECTION STEP TO THE MANUFACTURING PROCESS OF THE DEVICE. |