|
Device | Superion Indirect Decompression (IDS) System |
Generic Name | Prosthesis, spinous process spacer/plate |
Applicant | Boston Scientific Neuromodulation 25155 Rye Canyon Loop Valencia, CA 91355 |
PMA Number | P140004 |
Supplement Number | S018 |
Date Received | 06/17/2020 |
Decision Date | 08/05/2020 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a design and manufacturing change for an instrument component. |