FDA-Device2014-02-05Class II
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TM
Codman & Shurtleff, Inc.
Hazard
Codman Certas Programmable Valves used for hydrocephalus may not operate properly
Sold states
Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and UK.
Affected count
369 units
Manufactured in
325 Paramount Drive, Raynham, MA, United States
Products
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. The valve can be set to a choice of eight opening pressure settings for constant intraventricular perssure drainage of CSF. The CODMAN CERTAS Therapy Management System (TMS) allows the non-invasive reading or adjustment of the valve setting.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0862-2014Don't want to check this manually?
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