Spiration Valve System
FDA premarket approval P180007/S011 · decided 2023-09-22
Approval details
- PMA number
- P180007
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Spiration Valve System
- Generic name
- Valve, pulmonary
- Applicant
- Gyrus Acmi, Inc.
- Date received
- 2023-08-24
- Decision date
- 2023-09-22
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redmond, WA
- Statement
- Approval for the modification to the Informed Consent Template for the STRIVE Registry Study to permit payment to study participants for study visits.
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