Tula System
FDA premarket approval P190016/S002 · decided 2020-12-30
Approval details
- PMA number
- P190016
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Tula System
- Generic name
- Tympanostomy tube delivery product with drug
- Applicant
- Tusker Medical, Inc.
- Date received
- 2020-10-29
- Decision date
- 2020-12-30
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- QJA
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Tula Tympanostomy Tube Delivery Device (K252436) | Tusker Medical, Inc. | 2026-04-23 |