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 | SVS Deployment Catheter and Loader |
Generic Name | Valve, pulmonary |
Applicant | Gyrus ACMI, Inc. 6675 185th Avenue NE Redmond, WA 98052 |
PMA Number | P180007 |
Supplement Number | S009 |
Date Received | 04/12/2022 |
Decision Date | 05/12/2022 |
Product Code |
NJK |
Advisory Committee |
Anesthesiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Minor change to a manufacturing tool used in the assembly of the SVS Deployment Catheter and Loader. |
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