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 System |
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 | S002 |
Date Received | 10/29/2020 |
Decision Date | 12/30/2020 |
Product Code |
QJA |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a design modification to the Check Valve Assembly of the Earset of the Tula® System and for a 12-month expiration dating labeling claim for the modified Earset of Tula® System. |
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