PMA P090031S003
- Device
- MONOVISC
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S003
- Product code
- MOZ
- Decision date
- 2015-02-04
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- APPROVAL TO EXPAND THE SPECIFICATION FOR RESIDUAL METHANOL INMONOVISC FROM <= 0.05% TO <= 0.03% W/W TO BE IN ACCORDANCE WITH RESIDUAL SOLVENT TESTING LIMITS UNDER USP GENERAL CHAPTER <467>, TO REVISE THE STABILITY TESTING PROTOCOL FOR MONOVISC, AND TO EXTEND THE SHELF LIFE OF MONOVISC FROM 2 YEARS TO 3 YEARS UTILIZING THIS REVISED STABILITY TESTINGPROTOCOL.
Current openFDA PMA Record#
- Device
- MONOVISC
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S003
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2015-02-04
- Decision code
- APPR
- Date received
- 2014-11-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO EXPAND THE SPECIFICATION FOR RESIDUAL METHANOL INMONOVISC FROM