|
Device | ZYPLAST COLLAGEN IMPLANT ZYDERM I AND II COLLAGEN IMPLANT |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Allergan 71 SOUTH LOS CARNEROS ROAD GOLETA, CA 93117-5506 |
PMA Number | P800022 |
Supplement Number | S049 |
Date Received | 10/10/1995 |
Decision Date | 11/30/1995 |
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 | No |
Approval Order Statement APPROVAL FOR THE USE OF A RANGE OF FILL VOLUMES FOR THE ABOVE REFERENCED PRODUCTS FROM 0.1ML (TEST DOSE) TO 3ML |