PMA P180007

Device: Spiration Valve System (SVS)
Applicant: Gyrus Acmi, Inc.
PMA number: P180007
Supplement: S009
Product code: NJK
Decision date: 2026-05-07
Generic name: Valve, pulmonary
Approval order statement: The firm is submitting this 30-Day Notice of a change in the verification and validation process of the Water Treatment System. The firm is adding endotoxin testing for the water samples and related process modifications to the manufacturing work instruction.

Current openFDA PMA Record#

Device: Spiration Valve System (SVS)
Applicant: Gyrus Acmi, Inc.
PMA number: P180007
Supplement: S015
Product code: NJK
Generic name: Valve, pulmonary
Decision date: 2026-05-07
Decision code: OK30
Date received: 2026-04-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The firm is submitting this 30-Day Notice of a change in the verification and validation process of the Water Treatment System. The firm is adding endotoxin testing for the water samples and related process modifications to the manufacturing work instruction.