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.
The addition of two new cleanrooms (controlled environment rooms) to the existing manufacturing facility for the tula system
| Device | Tula System |
| Generic Name | Tympanostomy Tube Delivery Product With Drug |
| Applicant | Tusker Medical, Inc. |
| Date Received | 2021-08-09 |
| Decision Date | 2021-09-08 |
| PMA | P190016 |
| Supplement | S003 |
| Product Code | QJA |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Tusker Medical, Inc. 155 Jefferson Drive, Suite 200 menlo Park, CA 94025 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190016 | Original Filing | |
| S006 | 2022-09-22 | Real-time Process |
| S005 | 2022-08-24 | 30-day Notice |
| S004 | ||
| S003 | 2021-08-09 | 30-day Notice |
| S002 | 2020-10-29 | Real-time Process |
| S001 | 2020-04-09 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00840128600009 | P190016 | 000 |
| 00840128600016 | P190016 | 000 |
| 00840128600023 | P190016 | 000 |
| 00840128600030 | P190016 | 000 |
| 00840128600047 | P190016 | 000 |
| 20840128600058 | P190016 | 000 |
| 20840128600072 | P190016 | 000 |
| 20840128600089 | P190016 | 000 |
| 20840128600096 | P190016 | 000 |
| 20840128600102 | P190016 | 000 |
| 00840128600160 | P190016 | 000 |
| 20840128600201 | P190016 | 000 |
| 00840128600153 | P190016 | 000 |
| 00840128600146 | P190016 | 000 |
| 00840128600139 | P190016 | 000 |
| 20840128600126 | P190016 | 000 |
| 20840128600119 | P190016 | 000 |
| 20840128600201 | P190016 | 002 |
| 20840128600058 | P190016 | 002 |
| 00840128600030 | P190016 | 002 |
| 00840128600023 | P190016 | 002 |
| 00840128600016 | P190016 | 002 |
| 00840128600009 | P190016 | 002 |