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

DeviceSpiration® Valve System
Generic NameValve, Pulmonary
ApplicantGyrus ACMI, Inc.
Date Received2019-11-18
Decision Date2020-12-15
Product CodeNJK 
Advisory CommitteeAnesthesiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Gyrus ACMI, Inc. 6675 185th Avenue Ne redmond, WA 98052

Supplemental Filings

Supplement NumberDateSupplement Type
P180007Original Filing
S007 2020-10-21 Normal 180 Day Track No User Fee
S005 2019-11-18 Normal 180 Day Track
S003 2018-12-26 Normal 180 Day Track No User Fee
S002 2018-12-26 Normal 180 Day Track No User Fee


Device IDPMASupp
00896506002323 P180007 000
00896506002316 P180007 000
00896506002309 P180007 000
00896506002293 P180007 000
00896506002286 P180007 000
00896506002279 P180007 000

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