SVS Deployment Catheter and Loader
FDA premarket approval P180007/S009 · decided 2022-05-12
Approval details
- PMA number
- P180007
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SVS Deployment Catheter and Loader
- Generic name
- Valve, pulmonary
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2022-04-12
- Decision date
- 2022-05-12
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- Minor change to a manufacturing tool used in the assembly of the SVS Deployment Catheter and Loader.
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