PMA P020012S034

Device: Bellafill Dermal Filler
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P020012
Supplement: S034
Product code: LMH
Decision date: 2019-10-01
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Implement a change on the Sampling and Monitoring plan for the USP Purified Water and Pure Steam WFI in the Suneva Medical facility at San Diego, California.

Current openFDA PMA Record#

Device: Bellafill Dermal Filler
Applicant: Tiger Aesthetics Medical, LLC
PMA number: P020012
Supplement: S034
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2019-10-01
Decision code: OK30
Date received: 2019-09-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement a change on the Sampling and Monitoring plan for the USP Purified Water and Pure Steam WFI in the Suneva Medical facility at San Diego, California.