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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceSUPERION INTERSPINOUS SPACER
Generic NameProsthesis, spinous process spacer/plate
ApplicantBoston Scientific Neuromodulation
25155 Rye Canyon Loop
Valencia, CA 91355
PMA NumberP140004
Date Received03/31/2014
Decision Date05/20/2015
Product Code NQO 
Docket Number 15M-1957
Notice Date 06/18/2015
Advisory Committee Orthopedic
Clinical TrialsNCT00692276
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 
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