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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAspireAssist
Generic NameAspiration therapy system
ApplicantAspire Bariatrics, Inc.
3200 Horizon Dr.
Suite 100
King Of Prussia, PA 19406
PMA NumberP150024
Date Received07/08/2015
Decision Date06/14/2016
Withdrawal Date04/20/2022
Product Code OYF 
Docket Number 16m-1754
Notice Date 06/14/2016
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT01766037
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the AspireAssist® is intended to assist in weight reduction of obese patients. It is indicated for use in adults aged 22 or older with a Body Mass Index (BMI) of 35.0-55.0 kg/m2 who have failed to achieve and maintain weight loss with non-surgical weight loss therapy. The AspireAssist is intended for a long-term duration of use in conjunction with lifestyle therapy and continuous medical monitoring.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S008 S009 S010 S011 S012  S016 S001 S003 S004 S005 S006 
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