PMA P090031
- Device
- Monovisc
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S015
- Product code
- MOZ
- Decision date
- 2023-08-08
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Process improvement changes for p-Phenylene-bis-ethylcarbodiimide (BCDI) component of the Monvisc product
Current openFDA PMA Record#
- Device
- Monovisc
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S016
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2023-08-08
- Decision code
- OK30
- Date received
- 2023-07-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Process improvement changes for p-Phenylene-bis-ethylcarbodiimide (BCDI) component of the Monvisc product