PMA P190016S008
- Device
- Tula System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S008
- Product code
- QJA
- Decision date
- 2023-12-22
- Classification
- Ear, Nose, Throat
- Generic name
- Tympanostomy tube delivery product with drug
- Approval order statement
- Approval for the sterilization of the Gen 2 Tube Delivery System (TDS) at the new contract sterilizer, Sterigenics, located in Costa Rica
Current openFDA PMA Record#
- Device
- Tula System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S008
- Product code
- QJA
- Generic name
- Tympanostomy tube delivery product with drug
- Decision date
- 2023-12-22
- Decision code
- APPR
- Date received
- 2023-06-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the sterilization of the Gen 2 Tube Delivery System (TDS) at the new contract sterilizer, Sterigenics, located in Costa Rica