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 | S055 |
Date Received | 02/29/2012 |
Decision Date | 03/23/2012 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement UPDATES TO THE SOFTWARE USED TO DIRECT AND TRACK MANUFACTURING ACTIVITIES. |
|
|