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.
| Device | Tula® System |
| Classification Name | Tympanostomy Tube Delivery Product With Drug |
| Generic Name | Tympanostomy Tube Delivery Product With Drug |
| Applicant | Tusker Medical, Inc. |
| Date Received | 2019-05-31 |
| Decision Date | 2019-11-25 |
| Notice Date | 2019-11-27 |
| PMA | P190016 |
| Supplement | S |
| Product Code | QJA |
| Docket Number | 19M-5605 |
| Advisory Committee | Ear Nose & Throat |
| Expedited Review | No |
| 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 Number | Date | Supplement Type |
|---|
| P190016 | | Original Filing |
| S006 |
2022-09-22 |
Real-time Process |
| S005 |
2022-08-24 |
30-day Notice |
| S004 | | |
| S003 |
2021-08-09 |
30-day Notice |
| S002 |
2020-10-29 |
Real-time Process |
| S001 |
2020-04-09 |
30-day Notice |
NIH GUDID Devices