RHA Redensity, RHA 2, RHA 3, and RHA 4 dermal fillers

FDA Premarket Approval P170002 S021

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceRHA Redensity, RHA 2, RHA 3, and RHA 4 dermal fillers
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantTEOXANE S.A.les Charmillesrue De Lyon 105geneva 1203 PMA NumberP170002 Supplement NumberS021 Date Received03/17/2022 Decision Date06/14/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-03-17
Decision Date2022-06-14
PMAP170002
SupplementS021
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductYes
Applicant AddressTEOXANE S.A.
les Charmilles
rue De Lyon 105
geneva 1203 PMA NumberP170002 Supplement NumberS021 Date Received03/17/2022 Decision Date06/14/2022 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductYes Approval Order Statement  
Approval For Design Changes Of The Plunger And Finger Grip Of The Syringe.

Supplemental Filings

Supplement NumberDateSupplement Type
P170002Original Filing
S021 2022-03-17 Real-time Process
S020 2022-01-31 30-day Notice
S019 2021-07-26 Real-time Process
S018 2021-07-16 30-day Notice
S017 2021-04-26 30-day Notice
S016 2021-04-02 30-day Notice
S015 2021-03-29 30-day Notice
S014 2021-03-16 Special (immediate Track)
S013 2021-02-17 30-day Notice
S012
S011
S010 2020-07-20 135 Review Track For 30-day Notice
S009 2020-02-14 30-day Notice
S008 2020-02-13 30-day Notice
S007 2019-11-13 30-day Notice
S006
S005 2019-06-18 Real-time Process
S004 2019-03-12 135 Review Track For 30-day Notice
S003 2019-03-12 30-day Notice
S002 2019-02-21 30-day Notice
S001

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.