|
Device | REPLY DR/SR |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S046 |
Date Received | 06/17/2009 |
Decision Date | 07/15/2009 |
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 THE ADDITION OF AN INSPECTION STEP TO CHECK FOR EXCESSIVE SILICONE ADHESIVE IN THE SET SCREW CAVITY. |