Superion® Interspinous Spacer
FDA premarket approval P140004/S004 · decided 2016-10-11
Approval details
- PMA number
- P140004
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Superion® Interspinous Spacer
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2016-07-25
- Decision date
- 2016-10-11
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for a design modification to the Superion® implants and new labeling.
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