PMA P090031S002

Device: ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN
Applicant: Anika Therapeutics, Inc.
PMA number: P090031
Supplement: S002
Product code: MOZ
Decision date: 2014-07-08
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: CHANGE TO THE SYRINGE RESIDUAL SOLVENT TESTING FROM A SUPPLIERS CONTRACT LABORATORY TO THE SUPPLIERS IN-HOUSE FACILITY FOR ANIKAS OPHTHALMIC DEVICES.

Current openFDA PMA Record#

Device: ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN
Applicant: Anika Therapeutics, Inc.
PMA number: P090031
Supplement: S002
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2014-07-08
Decision code: OK30
Date received: 2014-06-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE SYRINGE RESIDUAL SOLVENT TESTING FROM A SUPPLIERS CONTRACT LABORATORY TO THE SUPPLIERS IN-HOUSE FACILITY FOR ANIKAS OPHTHALMIC DEVICES.