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Device | MACROPLASTIQUE IMPLANTS |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | UROPLASTY, LLC 5420 FELTL ROAD MINNETONKA, MN 55343 |
PMA Number | P040050 |
Date Received | 12/22/2004 |
Decision Date | 10/30/2006 |
Product Code |
LNM |
Docket Number | 06M-0457 |
Notice Date | 11/08/2006 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MACROPLASTIQUE IMPLANTS. THE DEVICE IS INDICATED FOR TRANSURETHRAL INJECTION IN THE TREATMENT OF ADULT WOMEN DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI) PRIMARILY DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S007 S008 S010 S011 S012 S013
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