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 | BRAVA,CONCERTO II, MAXIMO II PRTECTA CRT-D,CONCERTO CONSULTA,INSYNC II PROTECT, INSYNC III MARQUIS , INSYNC MAXIMOICD |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S438 |
Date Received | 03/28/2014 |
Decision Date | 05/23/2014 |
Product Code |
NVZ |
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 TO THE MYCARELINK PATIENT MONITOR24950. |
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