Spiration Valve System Deployment Catheter and Loader
FDA premarket approval P180007/S012 · decided 2024-06-27
Approval details
- PMA number
- P180007
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Spiration Valve System Deployment Catheter and Loader
- Generic name
- Valve, pulmonary
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2024-05-17
- Decision date
- 2024-06-27
- Days to decision
- 41 days
- Decision code
- OK30
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- changes to the manufacturing process of the thermal traverser and operator interface revisions of the thermal traverser
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