Bulkamid Urethral Bulking System

FDA Premarket Approval P170023 S003

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 changes in the primary packaging of bulkamid urethral bulking system (bulkamid rotatable sheath), upgrade to the corresponding process equipment, and replacement of the pouch sealing machine

DeviceBulkamid Urethral Bulking System
Generic NameAgent, Bulking, Injectable For Gastro-urology Use
ApplicantContura International A/S
Date Received2020-08-13
Decision Date2020-10-22
PMAP170023
SupplementS003
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
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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