PMA P090031S008
- Device
- MONOVISC High Molecular Weight Hyaluronan
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S008
- Product code
- MOZ
- Decision date
- 2017-08-21
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval for the addition of an alternative syringe stopper made with a different chemical formulation of rubber.
Current openFDA PMA Record#
- Device
- MONOVISC High Molecular Weight Hyaluronan
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S008
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2017-08-21
- Decision code
- APPR
- Date received
- 2017-05-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of an alternative syringe stopper made with a different chemical formulation of rubber.