Spiration® Valve System

FDA Premarket Approval P180007 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Change to eli grade nitinol as raw material for spiration valve frames

• Device: Spiration® Valve System
• Generic Name: Valve, Pulmonary
• Applicant: Gyrus ACMI, Inc.
• Date Received: 2019-11-18
• Decision Date: 2020-12-15
• PMA: P180007
• Supplement: S005
• Product Code: NJK
• Advisory Committee: Anesthesiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: Gyrus ACMI, Inc. 6675 185th Avenue Ne redmond, WA 98052

Supplemental Filings

Supplement Number	Date	Supplement Type
P180007		Original Filing
S009	2022-04-12	30-day Notice
S008	2021-04-30	Normal 180 Day Track No User Fee
S007	2020-10-21	Normal 180 Day Track No User Fee
S006
S005	2019-11-18	Normal 180 Day Track
S004
S003	2018-12-26	Normal 180 Day Track No User Fee
S002	2018-12-26	Normal 180 Day Track No User Fee
S001

NIH GUDID Devices

Device ID	PMA	Supp
00896506002323	P180007	000
00896506002316	P180007	000
00896506002309	P180007	000
00896506002293	P180007	000
00896506002286	P180007	000
00896506002279	P180007	000