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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceSpiration® Valve System
Generic NameValve, pulmonary
ApplicantGyrus Acmi, Inc.
6675 185th Ave. NE
Redmond, WA 98052
PMA NumberP180007
Supplement NumberS016
Date Received08/04/2026
Decision Date08/20/2026
Product Code NJK 
Advisory Committee Anesthesiology
Clinical TrialsNCT01812447
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180007.
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