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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 NumberS006
Date Received09/22/2022
Decision Date12/15/2022
Product Code QJA 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design modification to the firmware of the Iontophoresis Control Unit component of the Tula System.
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