PMA P090031S004
- Device
- MONOVISC INJECTABLE INTRA-ARTICULAR DEVICES
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S004
- Product code
- MOZ
- Decision date
- 2015-05-05
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- APPROVAL FOR AN ALTERNATE RAW MATERIAL SUPPLIER.
Current openFDA PMA Record#
- Device
- MONOVISC INJECTABLE INTRA-ARTICULAR DEVICES
- Applicant
- Anika Therapeutics, Inc.
- PMA number
- P090031
- Supplement
- S004
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2015-05-05
- Decision code
- APPR
- Date received
- 2014-12-24
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE RAW MATERIAL SUPPLIER.