|
Device | ENRHYTHM MRI EMDRO1; REVO MRI RVDRO1 |
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 | S132 |
Date Received | 02/25/2014 |
Decision Date | 04/24/2014 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00433654
|
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SIX SOFTWARE DEVICE APPLICATIONS ON THE ENCOREPROGRAMMER MODEL 29901. |
Post-Approval Study | Show Report Schedule and Study Progress |