Spiration Valve System

FDA Premarket Approval P180007 S008

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

The agency approves p180007/s008/a001 - gyrus acmi (spiration) pas revisions to emprove study protocol. Gyrus acmi (spiration) pas revisions to emprove study protocol. The sponsor submitted an amendment in which the requirements for investigator reports reporting uades, withdrawal of irb approval, progress, deviations, final report, and other reports have been restored. This amendment addresses deficiencies noted in fda letter dated may 28, 2021 from review of pma supplement p18007/s008 and following the june 9, 2021 gyrus-fda conference call which occurred to discuss clarification of the noted deficiencies. The reviewer team has reviewed the amendment that the sponsor provided. The deficiencies that the agency listed are resolved because sponsor has restored the sections that they removed cited in the deficiencies.

DeviceSpiration Valve System
Generic NameValve, Pulmonary
ApplicantGyrus ACMI, Inc.
Date Received2021-04-30
Decision Date2021-09-01
PMAP180007
SupplementS008
Product CodeNJK 
Advisory CommitteeAnesthesiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address Gyrus ACMI, Inc. 6675 185th Avenue Ne redmond, WA 98052

Supplemental Filings

Supplement NumberDateSupplement Type
P180007Original Filing
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 IDPMASupp
00896506002323 P180007 000
00896506002316 P180007 000
00896506002309 P180007 000
00896506002293 P180007 000
00896506002286 P180007 000
00896506002279 P180007 000

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