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 | CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S362 |
Date Received | 02/21/2013 |
Decision Date | 03/20/2013 |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement IC MANUFACTURE TEST CHANGES FOR THE ADVISA DR IPG A4DR01, ADVISA MRI IPG A2DR01,CONSULTA CRT-P C4TR01, SYNCRA CRT-P C2TR01, CONCERTO II CRT-D D274TRK, CONSULTA DF4 ICD D204TRM, CONSULTA ICD D224TRK,MAXIMO II CRT-D D264TRM, D284TRK, PROTECTA CRT-D D334TRG, D334TRM, PROTECTA XT CRT-D D314TRG, D314TRM, MAXIMO II ICD D264DRM, D264VRM, D284DRG, D284VRC, PROTECTA ICDD334DRG, D334DRM, D334VRG, D334VRM, PROTECTA XT ICD D314DRG, D314DRM, D314VRG, D314VRM, SECURA ICD D204DRM, D204VRM, D224DRG, D224VRC, VIRTUOSO II DR/VR ICD D274DRG AND D274VRC. |
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