PMA P190016S003
- Device
- Tula System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S003
- Product code
- QJA
- Decision date
- 2021-09-08
- Generic name
- Tympanostomy tube delivery product with drug
- Approval order statement
- Addition of two new cleanrooms (Controlled Environment Rooms) to the existing manufacturing facility for the Tula System.
Current openFDA PMA Record#
- Device
- Tula System
- Applicant
- Tusker Medical, Inc.
- PMA number
- P190016
- Supplement
- S003
- Product code
- QJA
- Generic name
- Tympanostomy tube delivery product with drug
- Decision date
- 2021-09-08
- Decision code
- OK30
- Date received
- 2021-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of two new cleanrooms (Controlled Environment Rooms) to the existing manufacturing facility for the Tula System.