PMA P140004S032
- Device
- Superion Indirect Decompression System (IDS)
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S032
- Product code
- NQO
- Decision date
- 2024-02-29
- Classification
- Orthopedic
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval for Labeling changes
Current openFDA PMA Record#
- Device
- Superion Indirect Decompression System (IDS)
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S032
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2024-02-29
- Decision code
- APPR
- Date received
- 2023-12-01
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for Labeling changes