|
Device | REPLY AND ESPIRIT FAMILY OF PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S075 |
Date Received | 02/19/2013 |
Decision Date | 03/13/2013 |
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 REINFORCEMENT OF AN EXISTING 100% IN-PROCESS SCREENING STEP INTENDED TO BE APPLIED FOR A LIMITED QUANTITY OF THREE (3) IDENTIFIED LOTS. |