EUFLEXXA (1% Sodium Hyaluronate)
FDA premarket approval P010029/S030 · decided 2020-04-16
Approval details
- PMA number
- P010029
- Supplement
- S030
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EUFLEXXA (1% Sodium Hyaluronate)
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2020-04-02
- Decision date
- 2020-04-16
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Change in manufacturing to shorten the time required for the concentration step during formulation by slightly increasing the pressure and reducing the concentration time in the UF (ultrafiltration) unit.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.