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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 DRIVE
SUITE 100
King of Prussia, PA 19406
PMA NumberP150024
Supplement NumberS012
Date Received09/25/2018
Decision Date10/24/2018
Withdrawal Date 04/20/2022
Product Code OYF 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the Physician Guide and Patient Guide.
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