PMA P170002S052

Device: RHA 2, RHA 3, RHA 4
Applicant: Teoxane S.A.
PMA number: P170002
Supplement: S052
Product code: LMH
Decision date: 2026-07-02
Classification: General, Plastic Surgery
Generic name: Implant, dermal, for aesthetic use
Approval order statement: Approval for the final labeling of RHA® Redensity Mepi. This follows the completion of the post-approval study to investigate whether RHA® Redensity™ Mepi (with mepivacaine) is non-inferior to RHA® Redensity™ (with lidocaine) for injection site pain felt during injection in FST V/VI subjects.

Current openFDA PMA Record#

Device: RHA 2, RHA 3, RHA 4
Applicant: Teoxane S.A.
PMA number: P170002
Supplement: S052
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2026-07-02
Decision code: APPR
Date received: 2026-01-06
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for the final labeling of RHA® Redensity Mepi. This follows the completion of the post-approval study to investigate whether RHA® Redensity™ Mepi (with mepivacaine) is non-inferior to RHA® Redensity™ (with lidocaine) for injection site pain felt during injection in FST V/VI subjects.