PMA P010029S002

Device

EUFLEXXA

Applicant

Ferring Pharmaceuticals, Inc.

PMA number

P010029

Supplement

S002

Product code

MOZ

Decision date

2005-10-20

Classification

Acid, Hyaluronic, Intraarticular

Generic name

Acid, hyaluronic, intraarticular

Approval order statement

APPROVAL FOR CHANGING THE TRADE NAME O THE PRODUCT FROM NUFLEXXA TO EUFLEXXA. THE DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).

Summary

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