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..
259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
Cleared
Nov 20, 2008
STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
Medtronic Neurosurgery
Neurology
35d
Cleared
Aug 27, 2008
STRATA NSC BURR HOLE VALVE, MODEL 42335
Medtronic Neurosurgery
Neurology
29d
Cleared
Jan 30, 2008
SMALL LUMEN PERITONEAL CATHETER
Medtronic Neurosurgery
Neurology
84d
Cleared
Dec 07, 2007
LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030
Integra LifeSciences Corporation
Neurology
52d
Cleared
Aug 16, 2007
RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715
Medtronic Neurosurgery
Neurology
233d
Cleared
Jan 17, 2007
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T
Aesculap, Inc.
Neurology
184d
Cleared
Oct 16, 2006
CODMAN VPV SYSTEM, MODEL 82-3192
Codman & Shurtleff, Inc.
Neurology
105d
Cleared
Sep 29, 2006
CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738
Codman & Shurtleff, Inc.
Neurology
115d
Cleared
Sep 27, 2006
MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS
Integra LifeSciences Corporation
Neurology
26d
Cleared
Sep 15, 2006
MEDTRONIC PS MEDICAL STRATA TYPE VALUE
Medtronic Neurosurgery
Neurology
184d
Cleared
Jan 19, 2006
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD
Codman & Shurtleff, Inc.
Neurology
76d
Cleared
Jan 19, 2006
MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS
Codman & Shurtleff, Inc.
Neurology
48d
Cleared
Dec 16, 2005
MEDTRONIC M2 MAGNET ADJUSTMENT TOOL
Medtronic Neurosurgery
Neurology
107d
Cleared
Jul 18, 2005
CODMAN VPV SYSTEM, MODEL 82-3192
Codman & Shurtleff, Inc.
Neurology
119d
Cleared
Jan 28, 2005
MEDTRONIC STRATAVARIUS
Medtronic Neurosurgery
Neurology
189d
Cleared
Dec 21, 2004
ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
Integra LifeSciences Corporation
Neurology
70d
Cleared
Dec 14, 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
Sophysa SA
Neurology
92d
Cleared
Nov 17, 2004
SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
Medical Designs, LLC
Neurology
78d
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