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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 Avenue NE
Redmond, WA 98052
PMA NumberP180007
Supplement NumberS003
Date Received12/26/2018
Decision Date05/21/2019
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
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) protocol.
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