PMA P090031S007
- Device
- MONOVISC
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S007
- Product code
- MOZ
- Decision date
- 2016-10-04
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Change from a manual manufacturing process to an automated process for the assembly of the syringe plunger rod and flange extender.
Current openFDA PMA Record#
- Device
- MONOVISC
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S007
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2016-10-04
- Decision code
- OK30
- Date received
- 2016-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change from a manual manufacturing process to an automated process for the assembly of the syringe plunger rod and flange extender.