|
Device | REVO MRI SURESCAN PACING SYSTEM |
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 | S012 |
Date Received | 03/29/2011 |
Decision Date | 05/27/2011 |
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 SOFTWARE APPLICATION SW005 VERSION 7.3 FOR CARELINK MODEL 2090 PROGRAMMER. |