PMA P170002S004

Device: RHA 2, RHA 3, RHA 4 dermal fillers
Applicant: Teoxane S.A.
PMA number: P170002
Supplement: S004
Product code: LMH
Decision date: 2019-11-01
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for implementation of the International Council for Harmonization (ICH) elemental impurities guideline and change in the test method and specification to assay aluminum by the raw material supplier for the hyaluronic acid.

Current openFDA PMA Record#

Device: RHA 2, RHA 3, RHA 4 dermal fillers
Applicant: Teoxane S.A.
PMA number: P170002
Supplement: S004
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2019-11-01
Decision code: APPR
Date received: 2019-03-12
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for implementation of the International Council for Harmonization (ICH) elemental impurities guideline and change in the test method and specification to assay aluminum by the raw material supplier for the hyaluronic acid.