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 ICD,CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, PROTECTA CRT-D, DF4 CRT-D, XT CRT-D, XT DR, XT DF4 CRT-D |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S310 |
Date Received | 08/21/2012 |
Decision Date | 03/26/2013 |
Product Code |
NIK |
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 FOR LABELING UPDATES TO INCORPORATE THE RESULTS OF THE RESPECT POST-APPROVAL STUDY FINAL REPORT, AND ADDITIONAL LABELING UPDATES. |
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