|
Device | CAPSUREFIX MRI SURESCAN 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 | S103 |
Date Received | 06/07/2013 |
Decision Date | 07/03/2013 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITIONAL STERILIZER SYSTEM AT MEDTRONICS SINGAPORE OPERATIONS. |