PMA P020012S030

Device: ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P020012
Supplement: S030
Product code: LMH
Decision date: 2019-07-11
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Implement a modification to the existing environmental sampling and monitoring plan of the Company's ISO Class 7 and Class 8 Cleanrooms.

Current openFDA PMA Record#

Device: ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P020012
Supplement: S030
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2019-07-11
Decision code: OK30
Date received: 2019-06-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement a modification to the existing environmental sampling and monitoring plan of the Company's ISO Class 7 and Class 8 Cleanrooms.