PMA P040001S019

Device: X-STOP INTERSPINOUS SPACER SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S019
Product code: NQO
Decision date: 2011-05-04
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: APPROVAL FOR IMPLEMENTATION OF NEW INSTRUMENT CLEANING AND STERILIZATION PROCESSES 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 THICKENED LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS AND/OR CENTRAL CANAL NARROWING). THE X-STOP SPACER 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 SPACER 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 SPACER SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S019
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2011-05-04
Decision code: APPR
Date received: 2011-03-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR IMPLEMENTATION OF NEW INSTRUMENT CLEANING AND STERILIZATION PROCESSES 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 THICKENED LIGAMENTUM FLAVUM, NARROWED LATERAL RECESS AND/OR CENTRAL CANAL NARROWING). THE X-STOP SPACER 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 SPACER MAY BE IMPLANTED AT ONE OR TWO LUMBAR LEVELS IN PATIENTS IN WHOM OPERATIVE TREATMENT IS INDICATED AT NO MORE THAN TWO LEVELS.