EUFLEXXA
FDA premarket approval P010029/S004 · decided 2007-08-23
Approval details
- PMA number
- P010029
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EUFLEXXA
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2006-09-18
- Decision date
- 2007-08-23
- Days to decision
- 339 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR A CHANGE IN INFLAMMATION TESTING FOR BULK SODIUM HYALURONATE FROM OXIDATIVE BURST TESTING TO AN IL-6 ELISA METHOD.
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