Tula® System

Tympanostomy Tube Delivery Product With Drug

FDA Premarket Approval P190016

Pre-market Approval Supplement Details

Approval for the tula® system. This device is intended to create a myringotomy and insert a tympanostomy tube using the tula tube delivery system in pediatric (aged 6 months and older) and adult patients indicated to receive tympanostomy tubes. The tula system is used to deliver a tympanostomy tube under local anesthesia induced using the tula iontophoresis system and tymbion™, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist. Tymbion™, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the tula® iontophoresis system in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the tula tube delivery systemdrug indications and usage: tymbion™, a combination of an amide local anesthetic and an alpha- and beta-adrenergic agonist, is indicated for the induction of local anesthesia of the tympanic membrane via iontophoresis using the tula® iontophoresis system in pediatric (aged 6 months and older) and adult patients undergoing tympanostomy tube placement using the tula tube delivery system.

DeviceTula® System
Classification NameTympanostomy Tube Delivery Product With Drug
Generic NameTympanostomy Tube Delivery Product With Drug
ApplicantTusker Medical, Inc.
Date Received2019-05-31
Decision Date2019-11-25
Notice Date2019-11-27
PMAP190016
SupplementS
Product CodeQJA
Docket Number19M-5605
Advisory CommitteeEar Nose & Throat
Expedited ReviewNo
Combination Product Yes
Applicant Address Tusker Medical, Inc. 155 Jefferson Drive, Suite 200 menlo Park, CA 94025
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P190016Original Filing

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