PMA P800022

Device
Zyderm I And Ii And Zyplast Collagen Implants
Applicant
Allergan
PMA number
P800022
Supplement
S048
Decision date
1996-02-01

Current openFDA PMA Record

Device
COSMODERM/ COSMOPLAST COLLAGEN IMPLANT, COSMODERM COSMOPLAST HUMAN-BASED COLLAGEN IMPLANT
Applicant
Allergan
PMA number
P800022
Supplement
S055
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2006-12-19
Decision code
APPR
Date received
2006-11-13
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A CHANGE IN THE GLUTARALDEHYDE CROSSLINKER CONCENTRATION.

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