DevicePMAs@therightstef:P190016_S000 JSONTXT 13 Projects

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.