RHA 2, RHA 3, RHA 4

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P170002

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the rh-2. The rha 2 is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (nlf), in adults aged 22 years or older. Rha 3 is indicated for injection into the mid-to-deep dermis for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (nlf), in adults aged 22 years or older. Rha 4 is indicated for injection into the deep dermis to superficial subcutaneous tissue for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (nlf), in adults aged 22 years or older.

DeviceRHA 2, RHA 3, RHA 4
Classification NameImplant, Dermal, For Aesthetic Use
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantTEOXANE S.A.
Date Received2017-01-17
Decision Date2017-10-19
Notice Date2017-10-23
PMAP170002
SupplementS
Product CodeLMH
Docket Number17M-6232
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
Combination Product Yes
Applicant Address TEOXANE S.A. rue De Lyon 105 geneva 1203
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

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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