Tula® System

FDA Premarket Approval P190016 S006

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

DeviceTula® System
Generic NameTympanostomy Tube Delivery Product With Drug
ApplicantTusker Medical, Inc.155 Jefferson Drive, Suite 200menlo Park, CA 94025 PMA NumberP190016 Supplement NumberS006 Date Received09/22/2022 Decision Date12/15/2022 Product Code QJA  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-09-22
Decision Date2022-12-15
PMAP190016
SupplementS006
Product CodeQJA 
Advisory CommitteeEar Nose & Throat
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductYes
Applicant AddressTusker Medical, Inc.
155 Jefferson Drive, Suite 200
menlo Park, CA 94025 PMA NumberP190016 Supplement NumberS006 Date Received09/22/2022 Decision Date12/15/2022 Product Code QJA  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductYes Approval Order Statement  
a Design Modification To The Firmware Of The Iontophoresis Control Unit Component Of The Tula System

Supplemental Filings

Supplement NumberDateSupplement Type
P190016Original 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 IDPMASupp
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00885556817667 P190016 007

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