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`Note: This medical device record is a PMA supplement. A supplement may have
`Note: This medical device record is a PMA supplement. A supplement may have
`changed the device description/function or indication from that approved in the original
`changed the device description /function or indication from that approved in the original
`PMA. Be sure to look at the original PMA record for more information.
`PMA. Be sure to look at the original PMA record for more information.
`
`Device
`Device
`Generic Name
`Generic Name
`Applicant
`Applicant
`
`PMA Number
`PMA Number
`Supplement Number
`Supplement Number
`Date Received
`Date Received
`Decision Date
`Decision Date
`
`COSMETIC TISSUE AUGMENTATION PRODUCT
`COSMETIC TISSUE AUGMENTATION PRODUCT
`Implant, Dermal, For Aesthetic Use
`Implant, Dermal, For Aesthetic Use
`
`Anika Therapeutics, Inc.
`Anika Therapeutics, Inc.
`32 Wiggins Avenue
`32 Wiggins Avenue
`Bedford, MA 01730
`Bedford, MA 01730
`P050033
`P050033
`S001
`S001
`01/03/2007
`01/03/2007
`07/16/2007
`07/16/2007
`
`Product Code
`Product Code
`
`LMH
`LMH
`
`Advisory Committee
`Advisory Committee
`Supplement Type
`Supplement Type
`Supplement Reason
`Supplement Reason
`Expedited Review Granted?
`Expedited Review Granted?
`
`General & Plastic Surgery
`General & Plastic Surgery
`Normal 180 Day Track
`Normal 180 Day Track
`Change Design/Components/Specifications/Material
`Change Design/ Components /Specifications /Material
`No
`No
`
`Combination Product
`Combination Product
`
`Yes
`Yes
`
`Approval Order Statement
`Approval Order Statement
`
`APPROVAL FOR: 1) AN INCREASE N THE BUFFER CONCENTRATION OF THE FINAL
`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
`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;
`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
`AND 3) THE INTRODUCTION OF AN 0.5 ML CONFIGURATION OF COSMETIC TISSUE
`AUGMENTATION PRODUCT (CTA).
`AUGMENTATION PRODUCT (CTA).
`
`Page Last Updated: 06/22/2020
`Page Last Updated: 06/22/2020
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