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 | CONCERTO II CRT-D,MAXIMO II CRT-D,CONSULTA CRT-D,CONSULTA CRT-D DF4,MAXIMO II CRT-D DF4 |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S414 |
Date Received | 12/18/2013 |
Decision Date | 07/09/2014 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MEDTRONIC VIVA CRT-P MODEL C6TR01 IMPLANTABLEPACEMAKER WITH CARDIAC RESYNCHRONIZATION; PROGRAMMER SOFTWARE APPLICATION MODEL 9995 V8.3; AND UPDATES TO THE MEDTRONIC CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL2020A AND CARELINK EXPRESS MODEL 2020B FIRMWARE, AND TO THE MODEL 2491 DEVICE DATA MANAGEMENT APPLICATION (DDMA). |
Approval Order | Approval Order |
|
|