P040001: X-STOP INTERSPINOUS SPACER SYSTEM

by MEDTRONIC SOFAMOR DANEK, INC.

Trade NameX-STOP INTERSPINOUS SPACER SYSTEM
Generic NameINTERSPINOUS PROCESS PROSTHESIS
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
PMA NumberP040001
Recent Supplement NumberS020
Contact
1800 PYRAMID PLACE
MEMPHIS, TN, 38132
Date ReceivedFeb 29, 2012
Decision DateJul 25, 2012
Product CodeNQO
Advisory CommitteeOR
Supplement TypeNORMAL 180 DAY TRACK NO USER FEE
Supplement ReasonLOCATION CHANGE: MANUFACTURER
Expedited Review Granted?N
Order Approval StatementAPPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SOFAMOR DANEK USA, INC. IN MEMPHIS, TENNESSEE.
sourcefda.gov
#Decision DateReason/TypeChange
S019May 04, 2011CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - OTHER/REAL-TIME PROCESSAPPROVAL FOR IMPLEMENTATION OF NEW INSTRUMENT CLEANING AND STERILIZATION PROCESSES AND IS INDICATED FOR TREATMENT OF PATIENTS AGED 50 OR OLDER SUFFERING FROM NEUROGENIC INTERMITTENT CLAUDICATION SECONDARY TO A CONFIRMED DIAGNOSIS OF LUMBAR SPINAL STENOSIS (WITH X-RAY, MRI, AND/OR CT EVIDENCE OF THICKENED LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS AND/OR CENTRAL CANAL NARROWING). THE X-STOP SPACER IS INDICATED FOR THOSE PATIENTS WITH MODERATELY IMPAIRED PHYSICAL FUNCTION WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/ BUTTOCK/GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND HAVE UNDERGONE A REGIMEN OF AT LEAST 6 MONTHS OF NONOPERATIVE TREATMENT. THE X-STOP SPACER MAY BE IMPLANTED AT ONE OR TWO LUMBAR LEVELS IN PATIENTS IN WHOM OPERATIVE TREATMENT IS INDICATED AT NO MORE THAN TWO LEVELS.
S017Jun 02, 2010POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEEAPPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
S016Apr 30, 2010CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACKAPPROVAL FOR ADDITIONAL SURGICAL INSTRUMENTS, CHANGES TO EXISTING INSTRUMENTS AND A NEW STERILIZATION TRAY. THESE NEW COMPONENTS INCLUDE THE SIZING DISTRACTOR, THE SPACER INSERTION INSTRUMENT WITH TRI-LOBE CONNECTORS, THE BI-DIRECTIONAL SIZING DISTRACTOR, THE HORIZONTAL HANDLE, THE TRIAL SPACERS, AND THE TWO-LEVEL STERILIZATION TRAY.
S012Jan 28, 2010LABELING CHANGE - INSTRUCTIONS/NORMAL 180 DAY TRACKAPPROVAL FOR A LABELING CHANGE TO ADD PLACEMENT OF THE PATIENT IN THE PRONE POSITION DURING IMPLANTATION OF THE DEVICE.
S015Oct 21, 2009LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK)APPROVAL FOR CHANGES TO THE DEVICE NAME, INSTRUCTIONS FOR USE, AND PHYSICIAN
S014Apr 16, 2009PROCESS CHANGE: MANUFACTURING/30-DAY NOTICECHANGE OF ADHESIVE USED IN THE MANUFACTURING PROCESS OF THE DEVICE.
S013Mar 11, 2009POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEEAPPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
S011Jan 14, 2009POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEEAPPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
S009Jul 09, 2008LABELING CHANGE - INSTRUCTIONS/SPECIAL(IMMEDIATE TRACK)APPROVAL FOR THE REVISION OF THE PHYSICIAN GUIDES AND INSTRUCTIONS FOR USE TO CLARIFY THE CONDITIONS UNDER WHICH THE X-STOP MAY BE RE-STERILIZED AND TO PROVIDE REVISED AND MORE DETAILED INSTRUCTIONS REGARDING ATTACHMENT OF THE WING ASSEMBLY TO THE SPACER ASSEMBLY.
S008Dec 14, 2007LOCATION CHANGE: MANUFACTURER/NORMAL 180 DAY TRACK NO USER FEEAPPROVAL FOR A MANUFACTURING SITE LOCATED AT KYPHON, INC., SUNNYVALE, CALIFORNIA, FOR INSPECTION, PACKAGING AND FINAL ACCEPTANCE.
S005Nov 20, 2007POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEEAPPROVAL OF THE POST-APPROVAL STUDY.
S007Oct 04, 2007CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACKAPPROVAL FOR A MODIFIED VERSION OF THE TISSUE EXPANDER OF THE TITANIUM VERSION OF THE X-STOP SPACER ASSEMBLY.
S004Dec 29, 2006/30-DAY NOTICETRANSFER OF RECEIVING, INSPECTION, ACCEPTANCE OF FINISHED GOODS, WAREHOUSING AND DISTRIBUTION FUNCTIONS TO THE NEW HEADQUARTERS FACILITY.
S001Dec 08, 2006POSTAPPROVAL PROTOCOL OR MODIFICATION TO A PROTOCOL/NORMAL 180 DAY TRACK NO USER FEEAPPROVAL OF THE POST-APPROVAL STUDY.
S003Oct 19, 2006PROCESS CHANGE: MANUFACTURING/30-DAY NOTICECHANGES IN PACKAGING FOOTPRINT, PACKAGING PROCESSES, LABELING PROCESSES AND MANUFACTURING FLOW FOR THE DEVICE.
S002Aug 08, 2006CHANGE DESIGN/COMPONENTS/SPECIFICATIONS - COMPONENT/NORMAL 180 DAY TRACKAPPROVAL FOR THE X STOPPK, A MODIFIED VERSION OF THE X STOP THAT INCLUDES A PEEK SPACER AND ADDITIONAL 16 MM SPACER SIZE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME X STOPPK AND IS INDICATED FOR TREATMENT OF PATIENTS AGED 50 OR OLDER SUFFERING FROM NEUROGENIC INTERMITTENT CLAUDICATION SECONDARY TO A CONFIRMED DIAGNOSIS OF LUMBAR SPINAL STENOSIS (WITH X-RAY, MRI, AND/OR CT EVIDENCE OF THICKENING LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS AND/OR CENTRAL CONAL NARROWING). THE X STOPPK IS INDICATED FOR THOSE PATIENTS WITH MODERATELY IMPAIRED PHYSICAL FUNCTION WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/BUTTOCK/GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND HAVE UNDERGONE A REGIMEN OF AT LEAST 6 MONTHS OF NONOPERATIVE TREATMENT. THE X STOPPK MAY BE IMPLANTED AT ONE OR TWO LUMBAR LEVELS IN PATIENTS IN WHOM OPERATIVE TREATMENT IS INDICATED AT NO MORE THAN TWO LEVELS.
Nov 21, 2005Original Approval APPROVAL FOR THE X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM. THE DEVICE IS INDICATED FOR TREATMENT OF PATIENTS AGED 50 OR OLDER SUFFERING FROM NEUROGENIC INTERMITTENT CLAUDICATION SECONDARY TO A CONFIRMED DIAGNOSIS OF LUMBAR SPINAL STENOSIS (WITH X-RAY, MRI, AND /OR CT EVIDENCE OF THICKENED LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS AND/OR CENTRAL CANAL NARROWING). THE X STOP IS INDICATED FOR THOSE PATIENTS WITH MODERATELY IMPAIRED PHYSICAL FUNCTION WHO EXPERIENCE RELIEF IN FLEXION FROM THEIR SYMPTOMS OF LEG/BUTTOCK/GROIN PAIN, WITH OR WITHOUT BACK PAIN, AND HAVE UNDERGONE A REGIMEN OF AT LEAST 6 MONTHS OF NONOPERATIVE TREATMENT. THE X STOP MAY BE IMPLANTED AT ONE OR TWO LUMBAR LEVELS IN PATIENTS IN WHOM OPERATIVE TREATMENT IS INDICATED AT NO MORE THAN TWO LEVELS.