Bulkamid Urethral Bulking System

FDA Premarket Approval P170023 S007

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 change in the sterilization site of the bulkamid needle, a component of the bulkamid urethral bulking system

DeviceBulkamid Urethral Bulking System
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantContura International A/S
Date Received2020-11-24
Decision Date2020-12-17
PMAP170023
SupplementS007
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
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
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000
05704101500500 P170023 000

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