PMA P040001S002

Device: X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S002
Product code: NQO
Decision date: 2006-08-08
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: APPROVAL 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.

Current openFDA PMA Record#

Device: X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S002
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2006-08-08
Decision code: APPR
Date received: 2006-03-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL 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.