PMA P140005S005
- Device
- GenVisc® 850
- Applicant
- Channel-Markers Medical, LLC
- PMA number
- P140005
- Supplement
- S005
- Product code
- MOZ
- Decision date
- 2023-06-22
- Classification
- Orthopedic
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Moving the manufacturing and sterilization site of the glass syringes (i.e., barrels) from BD Columbus, USA to BD Cuautitlán, Mexico.
Current openFDA PMA Record#
- Device
- GenVisc® 850
- Applicant
- Channel-Markers Medical, LLC
- PMA number
- P140005
- Supplement
- S005
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2023-06-22
- Decision code
- OK30
- Date received
- 2023-05-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Moving the manufacturing and sterilization site of the glass syringes (i.e., barrels) from BD Columbus, USA to BD Cuautitlán, Mexico.