Superion Indirect Decompression System
FDA premarket approval P140004/S016 · decided 2019-12-02
Approval details
- PMA number
- P140004
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Superion Indirect Decompression System
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2019-10-08
- Decision date
- 2019-12-02
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for modifications made to the packaging of the implant.
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