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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 NumberS009
Date Received08/07/2024
Decision Date01/31/2025
Product Code QJA 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at, RxCrossroads (“Clermont Site”)170 Clermont RoadSuite AShepherdsville, KY 40165;which performs the final kitting of the Tula System Drug Pack and logistics distribution of the Tula System (Tula Kit, Drug Pack, and spares) to customers, on behalf of Tusker Medical.
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