PMA P020012S006

Device
ARTEFILL® - PMMA COLLAGEN DERMAL FILLER
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S006
Product code
LMH
Decision date
2012-02-09
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SUNEVA MEDIAL, INC. IN SAN DIEGO, CALIFORNIA

Current openFDA PMA Record#

Device
ARTEFILL® - PMMA COLLAGEN DERMAL FILLER
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S006
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2012-02-09
Decision code
APPR
Date received
2011-12-28
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT SUNEVA MEDIAL, INC. IN SAN DIEGO, CALIFORNIA