X-STOP INTERSPINOUS DECOMPRESSION SYSTEM

FDA Premarket Approval P040001 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of the post-approval study.

DeviceX-STOP INTERSPINOUS DECOMPRESSION SYSTEM
Generic NameProsthesis, Spinous Process Spacer/plate
ApplicantMEDTRONIC SOFAMOR DANEK, INC.
Date Received2007-03-30
Decision Date2007-11-20
PMAP040001
SupplementS005
Product CodeNQO 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address MEDTRONIC SOFAMOR DANEK, INC. 1800 Pyramid Place memphis, TN 38132

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

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