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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.
 
DeviceAspireAssist
Generic NameAspiration therapy system
ApplicantAspire Bariatrics, Inc.
3200 Horizon Dr.
Suite 100
King Of Prussia, PA 19406
PMA NumberP150024
Supplement NumberS008
Date Received01/19/2018
Decision Date11/09/2018
Withdrawal Date04/20/2022
Product Code OYF 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the Companion, Tubing Set, Connector and Skin Port.
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