Superion® Indirect Decompression System
FDA premarket approval P140004/S015 · decided 2018-08-24
Approval details
- PMA number
- P140004
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Superion® Indirect Decompression System
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2018-06-22
- Decision date
- 2018-08-24
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- 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 Supe
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