Superion Indirect Decompression System (IDS)
FDA premarket approval P140004/S032 · decided 2024-02-29
Approval details
- PMA number
- P140004
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Superion Indirect Decompression System (IDS)
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2023-12-01
- Decision date
- 2024-02-29
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for Labeling changes
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