GENVISC 850
FDA premarket approval P140005 · decided 2015-09-02
Approval details
- PMA number
- P140005
- Trade name
- GENVISC 850
- Generic name
- Acid, hyaluronic, intraarticular
- Applicant
- Channel-Markers Medical, LLC
- Date received
- 2014-04-16
- Decision date
- 2015-09-02
- Days to decision
- 504 days
- Decision code
- APPR
- Product code
- MOZ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Raleigh, NC
- Statement
- APPROVAL FOR GENVISC 850®. THIS DEVICE IS INDICATED FOR OR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
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