|
Device | CAPSURE FIX MRI LEAD |
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 | S010 |
Date Received | 03/18/2011 |
Decision Date | 06/16/2011 |
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 | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE STERILE BARRIER TRAYS AND CHANGE IN ORIENTATION OF TOOLING ID NUMBER ON THE TRAY. |