SUPERION INTERSPINOUS SPACER
FDA premarket approval P140004 · decided 2015-05-20
Approval details
- PMA number
- P140004
- Trade name
- SUPERION INTERSPINOUS SPACER
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2014-03-31
- Decision date
- 2015-05-20
- Days to decision
- 415 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- 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 INDIC
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