DevicePMAs@therightstef:P190016_S000 JSONTXT

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{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P190016_S000","sourcedb":"DevicePMAs@therightstef","sourceid":"P190016_S000","text":"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 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