PMA P190016S007

Device: Tula® System
Applicant: Tusker Medical, Inc.
PMA number: P190016
Supplement: S007
Product code: QJA
Decision date: 2024-02-01
Classification: Ear, Nose, Throat
Generic name: Tympanostomy tube delivery product with drug
Approval order statement: which requested approval for modifications to the design of the Iontophoresis System (IPS) Earset and Tube Delivery System (TDS) components of the Tula System, collectively described as the next generation (“Tula Gen 2”), as well as modifications to the Tula System packaging configuration and tray sealing. Finally, your supplement requested approval for a Predetermined Change Control Plan (PCCP) for an alternate microcontroller component.

Current openFDA PMA Record#

Device: Tula® System
Applicant: Tusker Medical, Inc.
PMA number: P190016
Supplement: S007
Product code: QJA
Generic name: Tympanostomy tube delivery product with drug
Decision date: 2024-02-01
Decision code: APPR
Date received: 2023-04-05
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: which requested approval for modifications to the design of the Iontophoresis System (IPS) Earset and Tube Delivery System (TDS) components of the Tula System, collectively described as the next generation (“Tula Gen 2”), as well as modifications to the Tula System packaging configuration and tray sealing. Finally, your supplement requested approval for a Predetermined Change Control Plan (PCCP) for an alternate microcontroller component.