RHA 2, RHA 3, RHA 4 dermal fillers

FDA Premarket Approval P170002 S014

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

Approval for updated labeling to include adverse events from post market surveillance for rha 2, rha 3, and rha 4

DeviceRHA 2, RHA 3, RHA 4 dermal fillers
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantTEOXANE S.A.
Date Received2021-03-16
Decision Date2021-04-15
PMAP170002
SupplementS014
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address TEOXANE S.A. rue De Lyon 105 geneva 1203

Supplemental Filings

Supplement NumberDateSupplement Type
P170002Original Filing
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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