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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 Dr., Suite 200
Menlo Park, CA 94025
PMA NumberP190016
Supplement NumberS012
Date Received07/01/2026
Decision Date07/31/2026
Product Code QJA 
Advisory Committee Ear Nose & Throat
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
implementation of a new ethylene oxide (EO) sterilization cycle for the Tula Tube Delivery (TDS) component of the Tula System
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