|
Device | COSMODERM AND COSMOPLAST HUMAN-BASED COLLAGEN |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 71 SOUTH LOS CARNEROS ROAD GOLETA, CA 93117-5506 |
PMA Number | P800022 |
Supplement Number | S052 |
Date Received | 10/24/2003 |
Decision Date | 05/11/2004 |
Withdrawal Date
|
10/25/2011 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A NEW RAW MATERIAL SUPPLIER FOR THE HUMAN COLLAGEN COMPONENT OF COSMODERM AND COSMOPLAST (I.E., IMMUCOR/GAMMA BIOLOGICALS OF HOUSTON, TEXAS). |