|
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 | S013 |
Date Received | 03/23/2018 |
Decision Date | 04/19/2018 |
Product Code |
NQO |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Manufacture the modified Superion implant (Superion v2.0) by the second manufacturing site, Turner Medical. |