PMA P050033S020

Device: HYDRELLE
Applicant: Anika Therapeutics, Inc.
PMA number: P050033
Supplement: S020
Product code: LMH
Decision date: 2015-10-22
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: APPROVAL FOR LABELING MODIFICATIONS, AS REQUESTED IN FDAS LETTER TO MANUFACTURERS MARKETING SOFT TISSUE FILLER IMPLANTS ABOUT THE RISKS ASSOCIATED WITH VASCULAR INJECTION.

Current openFDA PMA Record#

Device: HYDRELLE
Applicant: Anika Therapeutics, Inc.
PMA number: P050033
Supplement: S020
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2015-10-22
Decision code: APPR
Date received: 2015-09-29
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING MODIFICATIONS, AS REQUESTED IN FDAS LETTER TO MANUFACTURERS MARKETING SOFT TISSUE FILLER IMPLANTS ABOUT THE RISKS ASSOCIATED WITH VASCULAR INJECTION.