PMA P190016S005
- Device
- Tula® System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S005
- Product code
- QJA
- Decision date
- 2022-09-22
- Generic name
- Tympanostomy tube delivery product with drug
- Approval order statement
- Modification to the adhesive application process for the earplug.
Current openFDA PMA Record#
- Device
- Tula® System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S005
- Product code
- QJA
- Generic name
- Tympanostomy tube delivery product with drug
- Decision date
- 2022-09-22
- Decision code
- OK30
- Date received
- 2022-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the adhesive application process for the earplug.