FDA Product Code JXG: Shunt, Central Nervous System And Components
Hydrocephalus is managed with shunt systems that divert excess cerebrospinal fluid. FDA product code JXG covers central nervous system shunts and their components.
These implanted systems typically consist of a ventricular catheter, a valve mechanism, and a distal catheter that diverts excess cerebrospinal fluid from the ventricles to the peritoneal cavity, pleura, or atrium. Programmable valves allow non-invasive adjustment of drainage pressure.
JXG devices are Class II medical devices, regulated under 21 CFR 882.5550 and reviewed by the FDA Neurology panel.
Leading manufacturers include Codman & Shurtleff, Inc., Holter-Hausner Intl. and Pudenz-Schulte Medical Research Corp..
260
Total
260
Cleared
126d
Avg days
1976
Since
260 devices
Cleared
Nov 02, 2004
SHUNTCHECK (PROMETHEUS 1)
Samuel Neff M.D.
Neurology
301d
Cleared
Oct 19, 2004
PS MEDICAL STRATA II VALVE
Medtronic Neurosurgery
Neurology
36d
Cleared
Oct 06, 2004
EQUI-FLOW VALVE AND SHUNT SYSTEM
Integra Neurosciences Implants S.A.
Neurology
15d
Cleared
Sep 24, 2004
PS MEDICAL NEUROSURGICAL IMPLANTS
Medtronic Neurosurgery
Neurology
42d
Cleared
Sep 02, 2004
LOW FLOW OSV II HYDROCEPHALUS VALVE
Integra Neurosciences Implants S.A.
Neurology
21d
Cleared
Jun 15, 2004
MEDTRONIC PS MEDICAL STRATA VALVE
Medtronic Neurosurgery
Neurology
64d
Cleared
Jun 10, 2004
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
Codman & Shurtleff, Inc.
Neurology
27d
Cleared
May 27, 2004
MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
Vygon Us, LLC
Neurology
184d
Cleared
Apr 07, 2004
PHOENIX INFUSION CATHETER
Phoenix Biomedical
Neurology
194d
Cleared
Feb 26, 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
Sophysa SA
Neurology
325d
Cleared
Feb 26, 2004
MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
Integra Neurosciences Implants S.A.
Neurology
28d
Cleared
Jan 13, 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
Medtronic Neurosurgery
Neurology
33d
Cleared
Dec 17, 2003
CONTOUR-FLEX VALVE AND SHUNT SYSTEM
Integra Neurosciences Implants S.A.
Neurology
22d
Cleared
Oct 15, 2003
ACURA ELITE GRAVITY COMPENSATING RESERVOIR
Phoenix Biomedical Corp.
Neurology
245d
Cleared
Oct 06, 2003
CSF400 AND CSF600
Inmed Ltda.
Neurology
270d
Cleared
Oct 06, 2003
EXTERNAL DRAINAGE SET
Integra Neurosciences Implants S.A.
Neurology
26d
Cleared
Jun 04, 2003
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
Aesculap, Inc.
Neurology
41d
Cleared
Mar 20, 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
Aesculap, Inc.
Neurology
14d
Cleared
Feb 26, 2003
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
Integra Lifesciences Corp.
Neurology
29d
Cleared
Jan 27, 2003
ACCURA ELITE SHUNT SYSTEM
Phoenix Biomedical Corp.
Neurology
52d
Cleared
Jan 27, 2003
PHOENIX UNIVERSAL SHUNT SYSTEM
Phoenix Biomedical Corp.
Neurology
46d
Cleared
Aug 23, 2002
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
Integra Neurosciences
Neurology
21d
Cleared
Aug 06, 2002
PERF (OMMAYA STYLE) RESERVOIRS
Phoenix Biomedical Corp.
Neurology
78d
Cleared
Jul 29, 2002
CODMAN BACTISEAL EVD CATHETER SET
Codman & Shurtleff, Inc.
Neurology
70d