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.
Supplement requested 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.
| Device | Tula System |
| Generic Name | Tympanostomy Tube Delivery Product With Drug |
| Applicant | Tusker Medical, Inc. |
| Date Received | 2020-10-29 |
| Decision Date | 2020-12-30 |
| PMA | P190016 |
| Supplement | S002 |
| Product Code | QJA |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |