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
PMAP180007
SupplementS005
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
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 IDPMASupp
00896506002323 P180007 000
00896506002316 P180007 000
00896506002309 P180007 000
00896506002293 P180007 000
00896506002286 P180007 000
00896506002279 P180007 000

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