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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.
 
DevicePathway Clinical Trial Cohort
Generic NameAspiration therapy system
ApplicantAspire Bariatrics, Inc.
3200 Horizon Dr.
Suite 100
King Of Prussia, PA 19406
PMA NumberP150024
Supplement NumberS016
Date Received10/29/2019
Decision Date04/24/2020
Withdrawal Date04/20/2022
Product Code OYF 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval including the ODE Lead PMA Post-Approval Study - Extended Follow-up of the Premarket Cohort (PATHWAY Clinical Trial) has been fulfilled.
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