This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the contigen™ bard® collagen implant. This device is indicated for use in the treatment of urinary incontinence due to intrinsic sphincter deficiency (poor or non-functioning bladder outlet mechanism) that may be helped by a locally injected bulking agent. Contigen implant therapy is intended only for patients who have shown no improvement in their incontinence for at least 12 months.
| Device | CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | Allergan, Inc. |
| Date Received | 1990-04-27 |
| Decision Date | 1993-09-30 |
| PMA | P900030 |
| Supplement | S |
| Product Code | LNM |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Allergan, Inc. 71 South Los Carneros Road goleta, CA 93111 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900030 | Original Filing | |
| S011 | 2009-03-03 | Normal 180 Day Track No User Fee |
| S010 | 2007-12-18 | Special (immediate Track) |
| S009 | 2005-06-13 | Normal 180 Day Track No User Fee |
| S008 | ||
| S007 | ||
| S006 | 1997-06-30 | Real-time Process |
| S005 | 1995-11-01 | Normal 180 Day Track |
| S004 | 1995-10-10 | Normal 180 Day Track |
| S003 | 1994-11-17 | Normal 180 Day Track |
| S002 | 1994-11-01 | Normal 180 Day Track |
| S001 | 1993-11-15 | Normal 180 Day Track |