TriVisc®
FDA premarket approval P160057/S002 · decided 2023-06-22
Approval details
- PMA number
- P160057
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TriVisc®
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.