PMA P050033S015

Device
S-15 HYDRELLE
Applicant
Anika Therapeutics, Inc.
PMA number
P050033
Supplement
S015
Product code
LMH
Decision date
2012-10-22
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
APPROVAL FOR A CHANGE IN THE SAMPLE PREPARATION PROCEDURE FOR HPLC TESTING.

Current openFDA PMA Record#

Device
S-15 HYDRELLE
Applicant
Anika Therapeutics, Inc.
PMA number
P050033
Supplement
S015
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2012-10-22
Decision code
APPR
Date received
2012-05-04
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A CHANGE IN THE SAMPLE PREPARATION PROCEDURE FOR HPLC TESTING.