PMA P180007S007
- Device
- Spiration® Valve System (SVS)
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S007
- Product code
- NJK
- Decision date
- 2020-12-23
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Spiration® Valve System (SVS)
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S007
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2020-12-23
- Decision code
- APPR
- Date received
- 2020-10-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.