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 | LOTUS Edge Valve System |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752-1234 |
PMA Number | P180029 |
Supplement Number | S018 |
Date Received | 11/25/2019 |
Decision Date | 12/17/2019 |
Withdrawal Date
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12/13/2021 |
Product Code |
NPT |
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 Several modifications to the equipment, software, and inspection associated with the Hydrodynamic Tester (HDT) used for valve inspections. |
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