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.
| Device | ALVEOFORM TM BIOGRAFT |
| Generic Name | Bone Grafting Material, Animal Source |
| Applicant | COLLAGEN CORP. |
| Date Received | 1988-11-09 |
| Decision Date | 1988-12-13 |
| PMA | P860012 |
| Supplement | S001 |
| Product Code | NPM |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COLLAGEN CORP. 2500 Faber Place palo Alto, CA 94303 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860012 | Original Filing | |
| S005 | 1994-11-01 | Normal 180 Day Track |
| S004 | 1990-08-31 | Special (immediate Track) |
| S003 | 1990-01-16 | Normal 180 Day Track |
| S002 | 1989-12-14 | Normal 180 Day Track |
| S001 | 1988-11-09 | Special (immediate Track) |