FDA.reportPublic FDA data

PMA P170002S012

Device
RHA® Redensity™
Applicant
Teoxane S.A.
Product code
LMH
Decision date
2021-12-22
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Approval for the RHA® Redensity is indicated for injection into the dermis and superficial dermis of the face, for the correction of moderate to severe dynamic perioral rhytids, in adults aged 22 years or older.

Current openFDA PMA Record#

Device
RHA® Redensity™
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S012
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2021-12-22
Decision code
APPR
Date received
2021-01-08
Supplement type
Panel Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the RHA® Redensity is indicated for injection into the dermis and superficial dermis of the face, for the correction of moderate to severe dynamic perioral rhytids, in adults aged 22 years or older.