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 |
Supplemental Filings
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 |
NIH GUDID Devices