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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCOAPTITE
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameinjectable implant for soft tissue augmenttation
ApplicantMERZ NORTH AMERICA, INC
PMA NumberP040047
Date Received12/13/2004
Decision Date11/10/2005
Product Code
LNM[ Registered Establishments with LNM ]
Docket Number 05M-0477
Notice Date 11/28/2005
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow 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 
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