PMA P020012S012

Device: ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P020012
Supplement: S012
Product code: LMH
Decision date: 2016-04-21
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for changes in the manufacturing process to remove a sampling step, split sterilization batch records, and add re-sieving steps.

Current openFDA PMA Record#

Device: ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P020012
Supplement: S012
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2016-04-21
Decision code: APPR
Date received: 2016-02-24
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changes in the manufacturing process to remove a sampling step, split sterilization batch records, and add re-sieving steps.