PMA P030019
- Device
- Orthovisc, Sodium Hyaluronic
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P030019
- Supplement
- S027
- Product code
- MOZ
- Decision date
- 2022-11-08
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Addition of an alternate supplier of fermented hyaluronic acid (HA) raw material for Orthovisc and Monovisc.
Current openFDA PMA Record#
- Device
- Orthovisc, Sodium Hyaluronic
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P030019
- Supplement
- S027
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2022-11-08
- Decision code
- OK30
- Date received
- 2022-10-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier of fermented hyaluronic acid (HA) raw material for Orthovisc and Monovisc.