|
Device | Bulkamid Urethral Bulking System |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | Axonics Modulation Technologies, Inc. 26 Technology Drive Irvine, CA 92618 |
PMA Number | P170023 |
Date Received | 07/31/2017 |
Decision Date | 01/28/2020 |
Product Code |
LNM |
Docket Number | 20M-0495 |
Notice Date | 01/30/2020 |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT00333073
|
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the Bulkamid Urethral Bulking System. The device is indicated for urethral injection for the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S001 S003 S005 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 |