PMA P030019S026
- Device
- Orthovisc
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P030019
- Supplement
- S026
- Product code
- MOZ
- Decision date
- 2021-07-02
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval for a new rubber stopper formulation for the 3 mL stoppers formulation.
Current openFDA PMA Record#
- Device
- Orthovisc
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P030019
- Supplement
- S026
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2021-07-02
- Decision code
- APPR
- Date received
- 2020-12-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new rubber stopper formulation for the 3 mL stoppers formulation.