PMA P190016
- Device
- Tula Tube Delivery System (TDS)
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S006
- Product code
- QJA
- Decision date
- 2026-01-21
- Generic name
- Tympanostomy tube delivery product with drug
- Approval order statement
- approval of a change in bacterial endotoxin testing (BET) from post-sterilization device samples to pre-sterilization device samples
Current openFDA PMA Record#
- Device
- Tula Tube Delivery System (TDS)
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S011
- Product code
- QJA
- Generic name
- Tympanostomy tube delivery product with drug
- Decision date
- 2026-01-21
- Decision code
- OK30
- Date received
- 2025-12-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of a change in bacterial endotoxin testing (BET) from post-sterilization device samples to pre-sterilization device samples