EUFLEXXA® (1% sodium hyaluronate)
FDA premarket approval P010029/S036 · decided 2024-02-02
Approval details
- PMA number
- P010029
- Supplement
- S036
- Supplement type
- 135 Review Track For 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
- 2023-08-30
- Decision date
- 2024-02-02
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for introduction of new silicone gaskets for ceramic membranes of the Ultrafiltration (UF3) formulation and filling unit used in the manufacturing of the Euflexxa (1% sodium hyaluronate) product.
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