PMA P180007S011
- Device
- Spiration Valve System
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S011
- Product code
- NJK
- Decision date
- 2023-09-22
- Classification
- Anesthesiology
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval for the modification to the Informed Consent Template for the STRIVE Registry Study to permit payment to study participants for study visits.
Current openFDA PMA Record#
- Device
- Spiration Valve System
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S011
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2023-09-22
- Decision code
- APPR
- Date received
- 2023-08-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the modification to the Informed Consent Template for the STRIVE Registry Study to permit payment to study participants for study visits.