PMA P170002S013

Device: RHA 2, RHA 3, RHA 4
Applicant: Teoxane S.A.
PMA number: P170002
Supplement: S013
Product code: LMH
Decision date: 2021-03-19
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Declare the change of analytical laboratory in charge of the assay of sodium hyaluronate (NaHA) content in the finished products at the release step for RHA2, RHA3, and RHA4.

Current openFDA PMA Record#

Device: RHA 2, RHA 3, RHA 4
Applicant: Teoxane S.A.
PMA number: P170002
Supplement: S013
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2021-03-19
Decision code: OK30
Date received: 2021-02-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Declare the change of analytical laboratory in charge of the assay of sodium hyaluronate (NaHA) content in the finished products at the release step for RHA2, RHA3, and RHA4.