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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 NumberS008
Date Received06/30/2023
Decision Date12/22/2023
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 the sterilization of the Gen 2 Tube Delivery System (TDS) at the new contract sterilizer, Sterigenics, located in Costa Rica
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