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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
Classification Nameaspiration therapy system
Generic Nameaspiration therapy system
Applicant
ASPIRE BARIATRICS INC
3200 horizon drive
suite 100
king of prussia, PA 19406
PMA NumberP150024
Supplement NumberS011
Date Received05/22/2018
Decision Date06/19/2018
Product Code
OYF[ Registered Establishments with OYF ]
Advisory Committee Gastroenterology/Urology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the A-tube IFU, Physician Guide and Patient Guide.
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