|
Device | Superion® Indirect Decompression System |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | Boston Scientific Neuromodulation 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P140004 |
Supplement Number | S010 |
Date Received | 11/16/2017 |
Decision Date | 11/16/2018 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revised labeling which incorporates data from the completed Post-Approval Study. |