RHA 2, RHA 3, RHA 4 dermal Fillers

FDA Premarket Approval P170002 S008

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

Minor corrections of the weight tolerances during gel mixing (before filling) in the device history record for rha®2, rha®3, rha®4

DeviceRHA 2, RHA 3, RHA 4 dermal Fillers
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantTEOXANE S.A.
Date Received2020-02-13
Decision Date2020-03-11
PMAP170002
SupplementS008
Product CodeLMH 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address TEOXANE S.A. rue De Lyon 105 geneva 1203

Supplemental Filings

Supplement NumberDateSupplement Type
P170002Original Filing
S009 0000-00-00
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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