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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 SystemTube Delivery System (TDS)
Generic Nametympanostomy tube delivery product with drug
Applicant
Tusker Medical, Inc.
155 jefferson drive, suite 200
menlo park, CA 94025
PMA NumberP190016
Supplement NumberS001
Date Received04/09/2020
Decision Date05/06/2020
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 Product Yes
Approval Order Statement 
Modification to the receiving inspection test method for the Barrel Cam, a component of the Tula Tube Delivery System.
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