Premarket Approval (PMA)

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.

• Device: Tula System
• Generic Name: Tympanostomy tube delivery product with drug
• Applicant: Tusker Medical, Inc.; 155 Jefferson Dr., Suite 200; Menlo Park, CA 94025
• PMA Number: P190016
• Supplement Number: S003
• Date Received: 08/09/2021
• Decision Date: 09/08/2021
• 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Addition of two new cleanrooms (Controlled Environment Rooms) to the existing manufacturing facility for the Tula System.