PMA P010029S007

Device

EUFLEXXA 1% SODIUM HYALURONATE

Applicant

Ferring Pharmaceuticals, Inc.

PMA number

P010029

Supplement

S007

Product code

MOZ

Decision date

2009-07-01

Classification

Acid, Hyaluronic, Intraarticular

Generic name

Acid, hyaluronic, intraarticular

Approval order statement

APPROVAL FOR THE STERILE SODIUM HYALURONATE (NAHA) TO BE STORED IN STERILE, DISPOSABLE POLYETHYLENE BAGS FOR UP TO 48 HOURS PRIOR TO FILLING THE SYRINGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EUFLEXXA AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.

Summary

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