Superion® Indirect Decompression System
FDA premarket approval P140004/S010 · decided 2018-11-16
Approval details
- PMA number
- P140004
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Superion® Indirect Decompression System
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2017-11-16
- Decision date
- 2018-11-16
- Days to decision
- 365 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for revised labeling which incorporates data from the completed Post-Approval Study.
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