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 include information from the post-approval study on cohort b.
| Device | CONTIGEN BARD COLLAGEN IMPLANT |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | Allergan, Inc. |
| Date Received | 2005-06-13 |
| Decision Date | 2006-09-21 |
| PMA | P900030 |
| Supplement | S009 |
| Product Code | LNM |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |