PMA P050033

Device
HYDRELLE DERMAL FILLER
Applicant
Anika Therapeutics, Inc.
PMA number
P050033
Supplement
S018
Product code
LMH
Decision date
2015-11-03
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
APPROVAL OF AN ALTERNATE SUPPLIER OF A MATERIAL USED IN THE MANUFACTURE HYDRELLE.

Current openFDA PMA Record#

Device
HYDRELLE DERMAL FILLER
Applicant
Anika Therapeutics, Inc.
PMA number
P050033
Supplement
S018
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2015-11-03
Decision code
APPR
Date received
2015-01-29
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL OF AN ALTERNATE SUPPLIER OF A MATERIAL USED IN THE MANUFACTURE HYDRELLE.