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. |
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Device | Tula SystemTube Delivery System (TDS) |
Generic Name | Tympanostomy tube delivery product with drug |
Applicant | Tusker Medical, Inc. 155 Jefferson Drive, Suite 200 Menlo Park, CA 94025 |
PMA Number | P190016 |
Supplement Number | S001 |
Date Received | 04/09/2020 |
Decision Date | 05/06/2020 |
Product Code |
QJA |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 30-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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