PMA P180007S009
- Device
- SVS Deployment Catheter and Loader
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S009
- Product code
- NJK
- Decision date
- 2022-05-12
- Generic name
- Valve, pulmonary
- Approval order statement
- Minor change to a manufacturing tool used in the assembly of the SVS Deployment Catheter and Loader.
Current openFDA PMA Record#
- Device
- SVS Deployment Catheter and Loader
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S009
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2022-05-12
- Decision code
- OK30
- Date received
- 2022-04-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Minor change to a manufacturing tool used in the assembly of the SVS Deployment Catheter and Loader.