Tympanostomy Tube Delivery Product With Drug
Basic Information
- Device Name
- Tympanostomy Tube Delivery Product With Drug
- Trade Name
- Tula® System
- PMA Number
- P190016
- Device Class
- FDA Class 3
- Product Code
- QJA
- Generic Name
- Tympanostomy tube delivery product with drug
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 25, 2019
- Date Received
- May 31, 2019
- Expedited Review
- N
- Docket Number
- 19M-5605
Advisory Committee Statement
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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QJA | Tympanostomy Tube Delivery Product With Drug | FDA class 3 | Unknown |