PMA P190016S001
- Device
- Tula SystemTube Delivery System (TDS)
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S001
- Product code
- QJA
- Decision date
- 2020-05-06
- Generic name
- Tympanostomy tube delivery product with drug
- Approval order statement
- Modification to the receiving inspection test method for the Barrel Cam, a component of the Tula Tube Delivery System.
Current openFDA PMA Record#
- Device
- Tula SystemTube Delivery System (TDS)
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S001
- Product code
- QJA
- Generic name
- Tympanostomy tube delivery product with drug
- Decision date
- 2020-05-06
- Decision code
- OK30
- Date received
- 2020-04-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the receiving inspection test method for the Barrel Cam, a component of the Tula Tube Delivery System.