|
Device | CAPSUREFIX MRI SURESCAN 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 | S059 |
Date Received | 03/12/2012 |
Decision Date | 04/23/2012 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A CHANGE TO THE PACKAGE CONFIGURATION FOR THE MODEL 5086 MRI SURESCAN LEAD. |