PMA P140005
- Device
- GenVisc 850
- Applicant
- Channel-Markers Medical, LLC
- PMA number
- P140005
- Supplement
- S004
- Product code
- MOZ
- Decision date
- 2025-05-20
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Addition of an alternate supplier of bulk sodium hyaluronate (HA) raw material for GenVisc 850 and Trivisc
Current openFDA PMA Record#
- Device
- GenVisc 850
- Applicant
- Channel-Markers Medical, LLC
- PMA number
- P140005
- Supplement
- S006
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2025-05-20
- Decision code
- OK30
- Date received
- 2025-05-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier of bulk sodium hyaluronate (HA) raw material for GenVisc 850 and Trivisc