PMA P050033S017

Device
HYDRELLE
Applicant
Anika Therapeutics, Inc.
PMA number
P050033
Supplement
S017
Product code
LMH
Decision date
2014-05-22
Classification
Implant, Dermal, For Aesthetic Use
Generic name
Implant, dermal, for aesthetic use
Approval order statement
TRANSFER OF RESIDUAL SOLVENT RELEASE TESTING FROM S&N LABORATORIES TO IN-HOUSE TESTING AT ANIKA THERAPEUTICS.

Current openFDA PMA Record#

Device
HYDRELLE
Applicant
Anika Therapeutics, Inc.
PMA number
P050033
Supplement
S017
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2014-05-22
Decision code
OK30
Date received
2014-05-01
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
TRANSFER OF RESIDUAL SOLVENT RELEASE TESTING FROM S&N LABORATORIES TO IN-HOUSE TESTING AT ANIKA THERAPEUTICS.