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 Drive, Suite 200menlo Park, CA 94025 PMA NumberP190016 Supplement NumberS006 Date Received09/22/2022 Decision Date12/15/2022 Product Code QJA Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-09-22 |
| Decision Date | 2022-12-15 |
| PMA | P190016 |
| Supplement | S006 |
| 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 PMA NumberP190016 Supplement NumberS006 Date Received09/22/2022 Decision Date12/15/2022 Product Code QJA Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductYes Approval Order Statement a Design Modification To The Firmware Of The Iontophoresis Control Unit Component Of The Tula System |
| 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 |