PMA P090031S009
- Device
- Monovisc
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S009
- Product code
- MOZ
- Decision date
- 2020-01-09
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval for inclusion of new clinical evidence in the labeling (Information for Prescribers) for Monovisc.
Current openFDA PMA Record#
- Device
- Monovisc
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S009
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2020-01-09
- Decision code
- APPR
- Date received
- 2019-07-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for inclusion of new clinical evidence in the labeling (Information for Prescribers) for Monovisc.