|
Device | CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI |
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 | S205 |
Date Received | 10/13/2015 |
Decision Date | 04/28/2016 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the expansion of MRI conditional labeling for the Advisa and Evera SureScan systems to 3T MRI. |
Post-Approval Study | Show Report Schedule and Study Progress |