PMA P020012S018

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S018
Product code
LMH
Decision date
2018-09-25
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for adding an alternate supplier as an approved source to perform sterility testing for product release
Summary
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Current openFDA PMA Record#

Device
Bellafill Dermal Filler
Applicant
Tiger Aesthetics Medical, LLC
PMA number
P020012
Supplement
S018
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2018-09-25
Decision code
APPR
Date received
2018-01-25
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for adding an alternate supplier as an approved source to perform sterility testing for product release