|
Device | MEDTRONIC 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 | S007 |
Date Received | 03/02/2011 |
Decision Date | 03/31/2011 |
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 REVISING PARAMETERS TO AN EPOXY DISPENSE MANUFACTURING PROCESS. |