|
Device | Superion® Interspinous Spacer |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | Boston Scientific Neuromodulation 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P140004 |
Supplement Number | S004 |
Date Received | 07/25/2016 |
Decision Date | 10/11/2016 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a design modification to the Superion® implants and new labeling. |