Superion Indirect Decompression (IDS) System
FDA premarket approval P140004/S018 · decided 2020-08-05
Approval details
- PMA number
- P140004
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Superion Indirect Decompression (IDS) System
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2020-06-17
- Decision date
- 2020-08-05
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for a design and manufacturing change for an instrument component.
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