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 CRT-D, MRI Quad CRT-D; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, MRI Quad CRT-D; Compia MRI CRT-D, MRI Quad |
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 | S659 |
Date Received | 02/25/2019 |
Decision Date | 03/26/2019 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement New external supplier for the dimer diamine for the Dadet epoxy. |
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