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:1) marketingthe current contigen implant product line in a modified packaging configuration instead of the current configuration, 2)changing the location of the skint test packaging operatin from collagen corp, fremont, ca, to bard urological div, covington, ga 3)revising the warning statement regarding connective tissue disease in the package inserts, patient brochures and safety summaries, and 4)updating the patient record and skin test card labeling
| Device | CONTIGEN BARD COLLAGEN IMPLANT |
| Generic Name | Agent, Bulking, Injectable For Gastro-urology Use |
| Applicant | Allergan, Inc. |
| Date Received | 1995-11-01 |
| Decision Date | 1996-03-08 |
| PMA | P900030 |
| Supplement | S005 |
| Product Code | LNM |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| 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 |