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 | Cobalt XT HF Quad CRT-D MRI SureScan, Coblat HF Quad CRT-D MRI SureScan, Cobalt HF CRT-D MRI SureScan, Crome HF QUad CRT |
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 | S742 |
Date Received | 03/31/2021 |
Decision Date | 06/29/2021 |
Product Code |
NIK |
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 to release new firmware RAMware to Cobalt and Crome ICD/CRT-D devices. |
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