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. |
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Device | REVO MRI IPG |
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 | S138 |
Date Received | 03/28/2014 |
Decision Date | 05/23/2014 |
Product Codes |
LWP NVN |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00433654
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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 TO THE MYCARELINK PATIENT MONITOR24950. |
Post-Approval Study | Show Report Schedule and Study Progress |
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