|
Device | COAPTITE |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | MERZ NORTH AMERICA, INC 4133 COURTNEY ROAD SUITE 10 FRANKSVILLE, WI 53126 |
PMA Number | P040047 |
Date Received | 12/09/2004 |
Decision Date | 11/10/2005 |
Product Code |
LNM |
Docket Number | 05M-0477 |
Notice Date | 11/28/2005 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR COAPTITE. THE DEVICE IS INDICATED FOR SOFT TISSUE AUGMENTATION IN THE TREATMENT OF STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD) IN ADULT FEMALES. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 S049 S051 S052 S053 S054 S055 S056 S057 S058 S061 S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 |