Tula System

FDA Premarket Approval P190016 S002

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

Supplement requested approval for a design modification to the check valve assembly of the earset of the tula® system and for a 12-month expiration dating labeling claim for the modified earset of tula® system.

DeviceTula System
Generic NameTympanostomy Tube Delivery Product With Drug
ApplicantTusker Medical, Inc.
Date Received2020-10-29
Decision Date2020-12-30
PMAP190016
SupplementS002
Product CodeQJA 
Advisory CommitteeEar Nose & Throat
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product Yes
Applicant Address Tusker Medical, Inc. 155 Jefferson Drive, Suite 200 menlo Park, CA 94025

Supplemental Filings

Supplement NumberDateSupplement Type
P190016Original Filing
S002 2020-10-29 Real-time Process
S001 2020-04-09 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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00840128600146 P190016 000
00840128600153 P190016 000
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00840128600009 P190016 000
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00840128600030 P190016 000
00840128600047 P190016 000
20840128600058 P190016 000
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20840128600096 P190016 000
20840128600102 P190016 000
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20840128600126 P190016 000
00840128600139 P190016 000
00840128600146 P190016 000
00840128600153 P190016 000
00840128600160 P190016 000
20840128600201 P190016 000
00840128600160 P190016 000
00840128600023 P190016 000
00840128600016 P190016 000
00840128600009 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
20840128600119 P190016 000
20840128600126 P190016 000
00840128600139 P190016 000
00840128600146 P190016 000
00840128600153 P190016 000
00840128600160 P190016 000
20840128600201 P190016 000
00840128600009 P190016 000

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