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Device | AspireAssist |
Generic Name | Aspiration therapy system |
Applicant | ASPIRE BARIATRICS INC 3200 HORIZON DRIVE SUITE 100 King of Prussia, PA 19406 |
PMA Number | P150024 |
Date Received | 07/08/2015 |
Decision Date | 06/14/2016 |
Withdrawal Date
|
04/20/2022 |
Product Code |
OYF |
Docket Number | 16m-1754 |
Notice Date | 06/14/2016 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT01766037
|
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S006 S005 S003 S004 S009 S010 S011 S008 S016 S012
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