PMA P020012S013

Device: Bellafill Dermal Filter
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P020012
Supplement: S013
Product code: LMH
Decision date: 2017-04-06
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: 1) Changed contract test lab and associated SOP for residual monomer in unprocessed PMMA microspheres; 2) Changed contract test lab and associated SOP for residual monomer in processed non-sterile PMMA microspheres; and 3) Added reference to internal manufacturing document and clarified rejectcriteria for finished product specification.

Current openFDA PMA Record#

Device: Bellafill Dermal Filter
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P020012
Supplement: S013
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2017-04-06
Decision code: OK30
Date received: 2017-03-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 1) Changed contract test lab and associated SOP for residual monomer in unprocessed PMMA microspheres; 2) Changed contract test lab and associated SOP for residual monomer in processed non-sterile PMMA microspheres; and 3) Added reference to internal manufacturing document and clarified rejectcriteria for finished product specification.