PMA P190016S012
- Device
- Tula® System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S012
- Product code
- QJA
- Decision date
- 2026-07-31
- Classification
- Ear, Nose, Throat
- Generic name
- Tympanostomy tube delivery product with drug
- Approval order statement
- implementation of a new ethylene oxide (EO) sterilization cycle for the Tula Tube Delivery (TDS) component of the Tula System
Current openFDA PMA Record#
- Device
- Tula® System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S012
- Product code
- QJA
- Generic name
- Tympanostomy tube delivery product with drug
- Decision date
- 2026-07-31
- Decision code
- OK30
- Date received
- 2026-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of a new ethylene oxide (EO) sterilization cycle for the Tula Tube Delivery (TDS) component of the Tula System