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PMA P190016S002

Device
Tula System
Applicant
Tusker Medical, Inc.
PMA number
P190016
Supplement
S002
Product code
QJA
Decision date
2020-12-30
Generic name
Tympanostomy tube delivery product with drug
Approval order statement
Approval for a design modification to the Check Valve Assembly of the Earset of the Tula® System and for a 12-month expiration dating labeling claim for the modified Earset of Tula® System.

Current openFDA PMA Record#

Device
Tula System
Applicant
Tusker Medical, Inc.
PMA number
P190016
Supplement
S002
Product code
QJA
Generic name
Tympanostomy tube delivery product with drug
Decision date
2020-12-30
Decision code
APPR
Date received
2020-10-29
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a design modification to the Check Valve Assembly of the Earset of the Tula® System and for a 12-month expiration dating labeling claim for the modified Earset of Tula® System.