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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 NumberS011
Date Received08/24/2023
Decision Date09/22/2023
Product Code NJK 
Advisory Committee Anesthesiology
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 for the modification to the Informed Consent Template for the STRIVE Registry Study to permit payment to study participants for study visits.
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