PMA P010029S008
- Device
- EUFLEXXA (1% SODIUM HYALURONATE)
- Applicant
- Ferring Pharmaceuticals, Inc.
- PMA number
- P010029
- Supplement
- S008
- Product code
- MOZ
- Decision date
- 2011-10-11
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- APPROVAL FOR EUFLEXXA (1% SODIUM HYALURONATE). THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVENON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P010029S008B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- EUFLEXXA (1% SODIUM HYALURONATE)
- Applicant
- Ferring Pharmaceuticals, Inc.
- PMA number
- P010029
- Supplement
- S008
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2011-10-11
- Decision code
- APPR
- Date received
- 2009-03-30
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR EUFLEXXA (1% SODIUM HYALURONATE). THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVENON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN).