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 | Amplia MRI Quad CRT-D, Claria MRI Quad CRT-D, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI 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 | S728 |
Date Received | 12/09/2020 |
Decision Date | 04/01/2021 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | normal 180 day track no user fee |
Supplement Reason | labeling change - pas |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the proposed clinical study summary labeling for the Multiple Point Pacing (MPP) Post Approval Clinical Study. |
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