PMA P020012S019

Device

Bellafill Dermal Filler

Applicant

Tiger Aesthetics Medical, LLC

PMA number

P020012

Supplement

S019

Product code

LMH

Decision date

2018-03-21

Classification

Implant, Dermal, For Aesthetic Use

Generic name

Implant, dermal, for aesthetic use

Approval order statement

Approval for the improvement of the Instructions for Use to ensure that end users are aware that these medical devices should be stored in refrigerated conditions until ready to use.

Summary

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