PMA P190016S009

Device: Tula® System
Applicant: Tusker Medical, Inc.
PMA number: P190016
Supplement: S009
Product code: QJA
Decision date: 2025-01-31
Classification: Ear, Nose, Throat
Generic name: Tympanostomy tube delivery product with drug
Approval order statement: approval for a manufacturing site located at, RxCrossroads (“Clermont Site”)170 Clermont RoadSuite AShepherdsville, KY 40165;which performs the final kitting of the Tula System Drug Pack and logistics distribution of the Tula System (Tula Kit, Drug Pack, and spares) to customers, on behalf of Tusker Medical.

Current openFDA PMA Record#

Device: Tula® System
Applicant: Tusker Medical, Inc.
PMA number: P190016
Supplement: S009
Product code: QJA
Generic name: Tympanostomy tube delivery product with drug
Decision date: 2025-01-31
Decision code: APPR
Date received: 2024-08-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at, RxCrossroads (“Clermont Site”)170 Clermont RoadSuite AShepherdsville, KY 40165;which performs the final kitting of the Tula System Drug Pack and logistics distribution of the Tula System (Tula Kit, Drug Pack, and spares) to customers, on behalf of Tusker Medical.