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 | Open Pivot Heart Valve, Open Pivot Aortic Valved Graft |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDTRONIC ATS MEDICAL, INC. 3800 ANNAPOLIS LANE, SUITE 175 PLYMOUTH, MN 55447 |
PMA Number | P990046 |
Supplement Number | S064 |
Date Received | 03/07/2022 |
Decision Date | 03/10/2022 |
Product Code |
LWQ |
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 Implement in-house verification of mass flow controllers used in the pyrolytic coating process. |
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