Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | REVO MRI |
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 | S136 |
Date Received | 03/18/2014 |
Decision Date | 05/16/2014 |
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 | No |
Approval Order Statement APPROVAL FOR FIRMWARE UPDATES (VERSION CM2490G_15V6) TO THE CARELINK MONITOR MODEL 2490G CARELINK HOME MONITORS, MODEL 2020A CARDIOSIGHT READER, AND MODEL 2020B CARELINK EXPRESS FOR A VARIETY OF IMPLANTED DEVICES. |
|
|