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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 NumberS007
Date Received04/05/2023
Decision Date02/01/2024
Product Code QJA 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedYes
Approval Order Statement  
which requested approval for modifications to the design of the Iontophoresis System (IPS) Earset and Tube Delivery System (TDS) components of the Tula System, collectively described as the next generation (“Tula Gen 2”), as well as modifications to the Tula System packaging configuration and tray sealing. Finally, your supplement requested approval for a Predetermined Change Control Plan (PCCP) for an alternate microcontroller component.
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