SUPERION INTERSPINOUS SPACER

Prosthesis, Spinous Process Spacer/plate

FDA Premarket Approval P140004

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 superion interspinous spacer (iss). This device is indicated to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without grade 1 spondylolisthesis, confirmed by x-ray, mri and/or ct evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The superion® iss is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The superion® iss may be implanted at one or two adjacent lumbar levels in patients in whom treatment is indicated at no more than two levels, from l1 to l5. For this intended use, moderate degenerative lumbar spinal stenosis was defined as follows:1) 25% to 50% reduction in the central canal and/or nerve root canal (subarticular, neuroforaminal) compared to the adjacent levels on radiographic studies, with radiographic confirmation of any one of the following:a) evidence of thecal sac and/or cauda equina compression;b) evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements; andc) evidence of hypertrophic facets with canal encroachment. 2) and associated with the following clinical signs:a) presents with moderately impaired physical function (pf) defined as a score of >= 2. 0 of the zurich claudication questionnaire (zcq); andb) ability to sit for 50 minutes without pain and to walk 50 feet or more.

DeviceSUPERION INTERSPINOUS SPACER
Classification NameProsthesis, Spinous Process Spacer/plate
Generic NameProsthesis, Spinous Process Spacer/plate
ApplicantVERTIFLEX (R), INCORPORATED
Date Received2014-03-31
Decision Date2015-05-20
Notice Date2015-06-18
PMAP140004
SupplementS
Product CodeNQO
Docket Number15M-1957
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address VERTIFLEX (R), INCORPORATED 2714 Loker Avenue West suite 100 carlsbad, CA 92010
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
P140004Original Filing
S029 2022-12-08 30-day Notice
S028 2021-12-03 Real-time Process
S027 2021-12-03 Normal 180 Day Track No User Fee
S026 2021-09-07 30-day Notice
S025 2021-07-30 30-day Notice
S024 2020-08-24 Normal 180 Day Track No User Fee
S023 2020-08-24 30-day Notice
S022
S021 2020-08-24 30-day Notice
S020
S019 2020-07-20 30-day Notice
S018 2020-06-17 Real-time Process
S017 2020-05-13 Normal 180 Day Track No User Fee
S016 2019-10-08 Real-time Process
S015 2018-06-22 Normal 180 Day Track
S014
S013 2018-03-23 30-day Notice
S012 2017-12-15 Normal 180 Day Track No User Fee
S011 2017-11-27 Normal 180 Day Track No User Fee
S010 2017-11-16 Normal 180 Day Track No User Fee
S009 2017-08-28 Normal 180 Day Track No User Fee
S008 2017-02-21 Normal 180 Day Track No User Fee
S007 2017-01-13 Normal 180 Day Track No User Fee
S006 2017-01-05 Normal 180 Day Track No User Fee
S005 2017-01-05 Normal 180 Day Track
S004 2016-07-25 Normal 180 Day Track
S003 2015-08-13 135 Review Track For 30-day Notice
S002 2015-06-22 Normal 180 Day Track No User Fee
S001 2015-06-22 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00884662000529 P140004 004

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