Bulkamid Urethral Bulking System

FDA Premarket Approval P170023 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

Modifications to the introducer sheath

DeviceBulkamid Urethral Bulking System
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantContura International A/S
Date Received2020-05-05
Decision Date2020-06-02
Product CodeLNM 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
S005 2020-09-04 Real-time Process
S003 2020-08-13 Real-time Process
S001 2020-05-05 30-day Notice


Device IDPMASupp
05704101500500 P170023 000

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