PMA P180007S005
- Device
- Spiration® Valve System
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S005
- Product code
- NJK
- Decision date
- 2020-12-15
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval for a change to ELI grade Nitinol as raw material for Spiration valve frames.
Current openFDA PMA Record#
- Device
- Spiration® Valve System
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S005
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2020-12-15
- Decision code
- APPR
- Date received
- 2019-11-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to ELI grade Nitinol as raw material for Spiration valve frames.