|
Device | CAPSURE FIX |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Medtronic, Inc 8200 Coral Sea Street NE Mounds View, MN 55112 |
PMA Number | P090013 |
Supplement Number | S028 |
Date Received | 06/08/2011 |
Decision Date | 11/18/2011 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT. |