Tula SystemTube Delivery System (TDS)

FDA Premarket Approval P190016 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

A modification to the receiving inspection test method for the barrel cam, a component of the tula tube delivery system

• Device: Tula SystemTube Delivery System (TDS)
• Generic Name: Tympanostomy Tube Delivery Product With Drug
• Applicant: Tusker Medical, Inc.
• Date Received: 2020-04-09
• Decision Date: 2020-05-06
• PMA: P190016
• Supplement: S001
• Product Code: QJA
• Advisory Committee: Ear Nose & Throat
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: Tusker Medical, Inc. 155 Jefferson Drive, Suite 200 menlo Park, CA 94025

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

Device ID	PMA	Supp
00840128600009	P190016	000
00840128600016	P190016	000
00840128600023	P190016	000
00840128600030	P190016	000
00840128600047	P190016	000
20840128600058	P190016	000
20840128600072	P190016	000
20840128600089	P190016	000
20840128600096	P190016	000
20840128600102	P190016	000
00840128600160	P190016	000
20840128600201	P190016	000
00840128600153	P190016	000
00840128600146	P190016	000
00840128600139	P190016	000
20840128600126	P190016	000
20840128600119	P190016	000
20840128600201	P190016	002
20840128600058	P190016	002
00840128600030	P190016	002
00840128600023	P190016	002
00840128600016	P190016	002
00840128600009	P190016	002