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 | 1994-11-01 |
Decision Date | 1995-03-21 |
PMA | P860012 |
Supplement | S005 |
Product Code | NPM |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
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) |