Bulkamid Urethral Bulking System

FDA Premarket Approval P170023 S005

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

Approval for minor changes to the bulkamid needle, including a change in the manufacturer for the bulkamid needle, which includes minor changes to the needle hub’s outershape, the raw materials used for the needle hub and sterile barrier system (pouch), and the dimensions of the needle pouch

DeviceBulkamid Urethral Bulking System
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantContura International A/S
Date Received2020-09-04
Decision Date2020-12-02
PMAP170023
SupplementS005
Product CodeLNM 
Advisory CommitteeGastroenterology/Urology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Contura International A/S sydmarken 23 soeborg 2860

Supplemental Filings

Supplement NumberDateSupplement Type
P170023Original Filing
S013 2022-09-27 30-day Notice
S012 2022-09-27 30-day Notice
S011 2022-07-08 30-day Notice
S010 2022-07-08 30-day Notice
S009 2022-07-08 30-day Notice
S008 2020-12-18 30-day Notice
S007 2020-11-24 30-day Notice
S006
S005 2020-09-04 Real-time Process
S004
S003 2020-08-13 Real-time Process
S002
S001 2020-05-05 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05704101500500 P170023 000
10810005340493 P170023 015

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