PMA P140004S015

Device

Superion® Indirect Decompression System

Applicant

Boston Scientific Neuromodulation

PMA number

P140004

Supplement

S015

Product code

NQO

Decision date

2018-08-24

Classification

Prosthesis, Spinous Process Spacer/plate

Generic name

Prosthesis, spinous process spacer/plate

Approval order statement

Approval of three (3) manufacturing sites for Structure Medical, LLC, located at: 111 Cayuga Drive, Mooresville, North Carolina, 28117 to manufacture components in versions 1 and 2 (v1.0 and v2.0) of the Superion® implant; 9935 Business Circle, Naples, Florida, 34112 to manufacture components in v1.0 and v2.0 of the Superion® implant, assemby and final inspections of the implants; and, 3511 Plover Avenue, Naples, Florida 34117 for passivation activities of components in v1.0 and v2.0 of the Superion® implant.

Summary

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