RHA 2, RHA 3, RHA 4 dermal fillers

FDA Premarket Approval P170002 S009

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

Addition of an alternative supplier of the reference standard lidocaine hydrochloride monohydrate used for the lidocaine assay 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 Received2020-02-14
Decision Date2020-03-10
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 2020-02-14 30-day Notice
S008 2020-02-13 30-day Notice
S007 2019-11-13 30-day Notice
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

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