RHA® Redensity™, RHA ®2, RHA ®3, RHA ®4 dermal fillers

FDA Premarket Approval P170002 S025

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, RHA ®4 dermal fillers
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantTEOXANE S.A.les Charmillesrue De Lyon 105geneva 1203 PMA NumberP170002 Supplement NumberS025 Date Received12/27/2022 Decision Date01/26/2023 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-12-27
Decision Date2023-01-26
PMAP170002
SupplementS025
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressTEOXANE S.A.
les Charmilles
rue De Lyon 105
geneva 1203 PMA NumberP170002 Supplement NumberS025 Date Received12/27/2022 Decision Date01/26/2023 Product Code LMH  Advisory Committee General & Plastic Surgery Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
manufacturing Change To Increase The Mixing Batch Size From 12L To 24L

Supplemental Filings

Supplement NumberDateSupplement Type
P170002Original Filing
S025 2022-12-27 30-day Notice
S024
S023
S022
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

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