PMA P180007

Device: Spiration® Valve System
Applicant: Gyrus Acmi, Inc.
PMA number: P180007
Supplement: S009
Product code: NJK
Decision date: 2026-08-20
Generic name: Valve, pulmonary
Approval order statement: Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180007.

Current openFDA PMA Record#

Device: Spiration® Valve System
Applicant: Gyrus Acmi, Inc.
PMA number: P180007
Supplement: S016
Product code: NJK
Generic name: Valve, pulmonary
Decision date: 2026-08-20
Decision code: APPR
Date received: 2026-08-04
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) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180007.