EUFLEXXA
FDA premarket approval P010029/S040 · decided 2024-09-23
Approval details
- PMA number
- P010029
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EUFLEXXA
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Ferring Pharmaceuticals, Inc.
- Date received
- 2024-08-26
- Decision date
- 2024-09-23
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- Approval for introduction of a new 1 ?m filter to be used during the second step of the bulk intermediate purification process for the manufacturing of the Euflexxa (1% sodium hyaluronate) product.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.