Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

PMA - Premarket Approval

Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA
 


New Search Back to Search Results
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
ApplicantBIOFORM MEDICAL, 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
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.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S006 S007 
S008 S009 S010 S011 S012 S013 
S014 S015 
 
-
-
-
-
-