PMA P170002S003

Device
RHA 2, RHA 3, RHA 4 dermal fillers
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S003
Product code
LMH
Decision date
2019-04-10
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
Change in the sterilization method of the empty syringe by the syringe supplier

Current openFDA PMA Record#

Device
RHA 2, RHA 3, RHA 4 dermal fillers
Applicant
Teoxane S.A.
PMA number
P170002
Supplement
S003
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2019-04-10
Decision code
OK30
Date received
2019-03-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the sterilization method of the empty syringe by the syringe supplier