PMA P020012S017

Device: Bellafill Dermal Filler
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P020012
Supplement: S017
Product code: LMH
Decision date: 2018-01-02
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Modification of the Bellafill tray by adding: 1) a stop shelf in the molded tray at a slight diagonal orientation to align the plunger end of the syringes; and 2) a flange indentation for placement of each syringe flange.

Current openFDA PMA Record#

Device: Bellafill Dermal Filler
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P020012
Supplement: S017
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2018-01-02
Decision code: OK30
Date received: 2017-12-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification of the Bellafill tray by adding: 1) a stop shelf in the molded tray at a slight diagonal orientation to align the plunger end of the syringes; and 2) a flange indentation for placement of each syringe flange.