PMA P090031S014
- Device
- Monovisc High Molecular Weight Hyaluronan
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S014
- Product code
- MOZ
- Decision date
- 2022-11-04
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Changes to in-process testing and final formulation steps in the product manufacturing process.
Current openFDA PMA Record#
- Device
- Monovisc High Molecular Weight Hyaluronan
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S014
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2022-11-04
- Decision code
- OK30
- Date received
- 2022-10-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to in-process testing and final formulation steps in the product manufacturing process.