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 DR MRI RVDR01 |
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 | S105 |
Date Received | 06/11/2013 |
Decision Date | 12/06/2013 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF LABELING CHANGES TO REMOVE THE RESTRICTION STATING THAT THE PATIENT MUST BE POSITIONED WITHIN THE BORE SUCH THAT THE ISOCENTER (CENTER OF THE MRI BORE) IS SUPERIOR TO THE C1 VERTEBRA OR INFERIOR TO THE T12 VERTEBRA AS WELL AS TO REMOVE THE REQUIREMENT THAT MRI SCANS NOT BE PERFORMED ON PATIENTS WITH OTHER PREVIOUSLY IMPLANTED MEDICAL DEVICES. |
|
|