PMA P050033S001

Device: COSMETIC TISSUE AUGMENTATION PRODUCT
Applicant: Anika Therapeutics, Inc.
PMA number: P050033
Supplement: S001
Product code: LMH
Decision date: 2007-07-16
Classification: Implant, Dermal, For Aesthetic Use
Generic name: Implant, dermal, for aesthetic use
Approval order statement: APPROVAL FOR: 1) AN INCREASE N THE BUFFER CONCENTRATION OF THE FINAL PRODUCT FROM 12 MM TO 50 MM SODIUM PHOSPHATE; 2) THE INTRODUCTION OF AN ANTIOXIDANT, I.E., 0.1% SODIUM METABISULFITE, INTO THE FINAL PRODUCT; AND 3) THE INTRODUCTION OF AN 0.5 ML CONFIGURATION OF COSMETIC TISSUE AUGMENTATION PRODUCT (CTA).

Current openFDA PMA Record#

Device: COSMETIC TISSUE AUGMENTATION PRODUCT
Applicant: Anika Therapeutics, Inc.
PMA number: P050033
Supplement: S001
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2007-07-16
Decision code: APPR
Date received: 2007-01-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR: 1) AN INCREASE N THE BUFFER CONCENTRATION OF THE FINAL PRODUCT FROM 12 MM TO 50 MM SODIUM PHOSPHATE; 2) THE INTRODUCTION OF AN ANTIOXIDANT, I.E., 0.1% SODIUM METABISULFITE, INTO THE FINAL PRODUCT; AND 3) THE INTRODUCTION OF AN 0.5 ML CONFIGURATION OF COSMETIC TISSUE AUGMENTATION PRODUCT (CTA).