PMA P190016S006
- Device
- Tula® System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S006
- Product code
- QJA
- Decision date
- 2022-12-15
- Generic name
- Tympanostomy tube delivery product with drug
- Approval order statement
- Approval for a design modification to the firmware of the Iontophoresis Control Unit component of the Tula System.
Current openFDA PMA Record#
- Device
- Tula® System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S006
- Product code
- QJA
- Generic name
- Tympanostomy tube delivery product with drug
- Decision date
- 2022-12-15
- Decision code
- APPR
- Date received
- 2022-09-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design modification to the firmware of the Iontophoresis Control Unit component of the Tula System.