GenVisc® 850
FDA premarket approval P140005/S005 · decided 2023-06-22
Approval details
- PMA number
- P140005
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GenVisc® 850
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Channel-Markers Medical, LLC
- Date received
- 2023-05-02
- Decision date
- 2023-06-22
- Days to decision
- 51 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- Moving the manufacturing and sterilization site of the glass syringes (i.e., barrels) from BD Columbus, USA to BD Cuautitlán, Mexico.
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