X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM

FDA Premarket Approval P040001

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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.

DeviceX STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Generic NameProsthesis, Spinous Process Spacer/plate
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
Date Received2004-01-06
Decision Date2005-11-21
Notice Date2006-01-13
PMAP040001
SupplementS
Product CodeNQO 
Docket Number06M-0014
Advisory CommitteeOrthopedic
Expedited ReviewYes
Combination Product No
Applicant Address MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place memphis, TN 38132
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P040001Original Filing
S022 2014-08-26 Normal 180 Day Track No User Fee
S021 2013-08-05 Normal 180 Day Track No User Fee
S020 2012-02-29 Normal 180 Day Track No User Fee
S019 2011-03-08 Real-time Process
S018
S017 2010-01-07 Normal 180 Day Track No User Fee
S016 2009-11-05 Normal 180 Day Track
S015 2009-09-24 Special (immediate Track)
S014 2009-03-19 30-day Notice
S013 2009-01-09 Normal 180 Day Track No User Fee
S012 2009-02-09 Normal 180 Day Track
S011 2008-06-26 Normal 180 Day Track No User Fee
S010
S009 2008-01-30 Special (immediate Track)
S008 2007-10-26 Normal 180 Day Track No User Fee
S007 2007-06-06 Normal 180 Day Track
S006
S005 2007-03-30 Normal 180 Day Track No User Fee
S004 2006-12-14 30-day Notice
S003 2006-09-19 30-day Notice
S002 2006-03-01 Normal 180 Day Track
S001 2006-01-23 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00858196001895 P040001 000
00613994455499 P040001 000
00613994598684 P040001 000
00613994598677 P040001 000
00613994598660 P040001 000
00613994579980 P040001 000
00613994598592 P040001 000
00613994598585 P040001 000
00613994598578 P040001 000
00613994598691 P040001 000
00613994455482 P040001 000
00613994455475 P040001 000
00613994455468 P040001 000
00843889000293 P040001 000
00843889000200 P040001 000
00613994598561 P040001 000
00843889000125 P040001 000
00613994455444 P040001 000
00613994598707 P040001 000
00613994455451 P040001 000
00613994598714 P040001 002
00613994598745 P040001 002
00613994598738 P040001 002
00613994598653 P040001 002
00613994598547 P040001 002
00613994598721 P040001 002
00843889000149 P040001 002
00613994455437 P040001 002
00843889000217 P040001 002
00613994580115 P040001 019
00613994579898 P040001 019
00613994580054 P040001 019
00613994579850 P040001 019
00613994580139 P040001 019
00613994579904 P040001 019
00613994580016 P040001 019
00613994580030 P040001 019
00613994580078 P040001 019
00613994580092 P040001 019
00643169132832 P040001 020
00643169117662 P040001 020
00643169117549 P040001 020
00643169117730 P040001 020
00643169117747 P040001 020
00643169117754 P040001 020
00643169117761 P040001 020
00643169132702 P040001 020
00643169132719 P040001 020
00643169132726 P040001 020
00643169132733 P040001 020
00643169132740 P040001 020
00643169132801 P040001 020
00643169132818 P040001 020
00643169132825 P040001 020
00643169132849 P040001 020
00643169117723 P040001 020
00643169117716 P040001 020
00643169117556 P040001 020
00643169117587 P040001 020
00643169117594 P040001 020
00643169117600 P040001 020
00643169117617 P040001 020
00643169117624 P040001 020
00643169117631 P040001 020
00643169117648 P040001 020
00643169117655 P040001 020
00643169117679 P040001 020
00643169117686 P040001 020
00643169117693 P040001 020
00643169117709 P040001 020
00643169132856 P040001 020

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.