This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for revised directions for use (dfu) that includes information from the post-approval study on cohort c. The device, as modified, will be marketed under the trade name contigen bard collagen implant and is indicated for use only in the treatment of urinary incontinence due to intrinsic sphincter deficiency (isd, poor or nonfunctioning bladder outlet mechanism) that may be helped by a locally injected bulking agent. Contigen implant therapy should be initiated only in patients who have shown no improvement in their incontinence for at least 12 months.
| Device | CONTIGEN BARD COLLAGEN IMPLANT |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | Allergan, Inc. |
| Date Received | 2009-03-03 |
| Decision Date | 2009-10-02 |
| PMA | P900030 |
| Supplement | S011 |
| Product Code | LNM |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Allergan, Inc. 71 South Los Carneros Road goleta, CA 93111 |
| 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 |