PMA P190016S010
- Device
- Tula® System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S010
- Product code
- QJA
- Decision date
- 2025-10-24
- Classification
- Ear, Nose, Throat
- Generic name
- Tympanostomy tube delivery product with drug
- Approval order statement
- approval for removal of lot release testing for Tula Tube Delivery System (TDS)
Current openFDA PMA Record#
- Device
- Tula® System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S010
- Product code
- QJA
- Generic name
- Tympanostomy tube delivery product with drug
- Decision date
- 2025-10-24
- Decision code
- OK30
- Date received
- 2025-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for removal of lot release testing for Tula Tube Delivery System (TDS)