Tula® System
FDA premarket approval P190016/S007 · decided 2024-02-01
Approval details
- PMA number
- P190016
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tula® System
- Generic name
- Tympanostomy tube delivery product with drug
- Applicant
- Tusker Medical, Inc.
- Date received
- 2023-04-05
- Decision date
- 2024-02-01
- Days to decision
- 302 days
- Decision code
- APPR
- Product code
- QJA
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- which requested approval for modifications to the design of the Iontophoresis System (IPS) Earset and Tube Delivery System (TDS) components of the Tula System, collectively described as the next generation (Tula Gen 2), as well as modifications to the Tula System packaging configuration and tray sealing. Finally, your supplement requested approval for a Predetermined Change Control Plan (PCCP) for an alternate microcontroller component.
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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 |