PMA P140005S004
- Device
- GenVisc 850
- Applicant
- Channel-Markers Medical, LLC
- PMA number
- P140005
- Supplement
- S004
- Product code
- MOZ
- Decision date
- 2020-06-07
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval for revision of the instructions for administration of GenVisc 850 to help prevent any leakage of the product during administration.
Current openFDA PMA Record#
- Device
- GenVisc 850
- Applicant
- Channel-Markers Medical, LLC
- PMA number
- P140005
- Supplement
- S004
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2020-06-07
- Decision code
- APPR
- Date received
- 2020-05-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revision of the instructions for administration of GenVisc 850 to help prevent any leakage of the product during administration.