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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 NumberS005
Date Received11/18/2019
Decision Date12/15/2020
Product Code NJK 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change to ELI grade Nitinol as raw material for Spiration valve frames.
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