Superion Indirect Decompression System
FDA premarket approval P140004/S011 · decided 2018-04-09
Approval details
- PMA number
- P140004
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Superion Indirect Decompression System
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2017-11-27
- Decision date
- 2018-04-09
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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