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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.
Classification Nameaspiration therapy system
Generic Nameaspiration therapy system
3200 horizon drive
suite 100
king of prussia, PA 19406
PMA NumberP150024
Supplement NumberS010
Date Received05/01/2018
Decision Date01/15/2019
Product Code
OYF[ Registered Establishments with OYF ]
Advisory Committee Gastroenterology/Urology
Clinical Trials NCT01766037
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the revised protocol with modifications including use of local labs for blood work, changes to the minimum and maximum number of patients enrolled per site, and a revised study timeline for the post-approval study (PAS) protocol.