|
Device | CAPSUREFIX 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 | S145 |
Date Received | 06/16/2014 |
Decision Date | 07/08/2014 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00433654
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement ADD A HELIX LINEARITY INSPECTION AT THE FINAL FUNCTIONAL INSPECTION AND A HELIX LINEARITY FIXTURE TO FACILITATE THIS LINEARITY INSPECTION. |
Post-Approval Study | Show Report Schedule and Study Progress |