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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 Tube Delivery System (TDS)
Generic NameTympanostomy tube delivery product with drug
ApplicantTusker Medical, Inc.
155 Jefferson Dr., Suite 200
Menlo Park, CA 94025
PMA NumberP190016
Supplement NumberS011
Date Received12/22/2025
Decision Date01/21/2026
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  
approval of a change in bacterial endotoxin testing (BET) from post-sterilization device samples to pre-sterilization device samples
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