PMA P180007S002
- Device
- Spiration Valve System
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S002
- Product code
- NJK
- Decision date
- 2019-03-01
- Classification
- Valve, Pulmonary
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval for the post-approval study (PAS) protocol on the extension of EMPROVE pivotal study for the Spiration Valve System
Current openFDA PMA Record#
- Device
- Spiration Valve System
- Applicant
- Gyrus Acmi, Inc.
- PMA number
- P180007
- Supplement
- S002
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2019-03-01
- Decision code
- APPR
- Date received
- 2018-12-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the post-approval study (PAS) protocol on the extension of EMPROVE pivotal study for the Spiration Valve System