PMA P180007S012
- Device
- Spiration Valve System Deployment Catheter and Loader
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S012
- Product code
- NJK
- Decision date
- 2024-06-27
- Classification
- Anesthesiology
- Generic name
- Valve, pulmonary
- Approval order statement
- changes to the manufacturing process of the thermal traverser and operator interface revisions of the thermal traverser
Current openFDA PMA Record#
- Device
- Spiration Valve System Deployment Catheter and Loader
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S012
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2024-06-27
- Decision code
- OK30
- Date received
- 2024-05-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the manufacturing process of the thermal traverser and operator interface revisions of the thermal traverser