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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.
 
DeviceTula System
Generic NameTympanostomy tube delivery product with drug
ApplicantTusker Medical, Inc.
155 Jefferson Drive, Suite 200
Menlo Park, CA 94025
PMA NumberP190016
Supplement NumberS002
Date Received10/29/2020
Decision Date12/30/2020
Product Code QJA 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for a design modification to the Check Valve Assembly of the Earset of the Tula® System and for a 12-month expiration dating labeling claim for the modified Earset of Tula® System.
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