PMA P140004S018
- Device
- Superion Indirect Decompression (IDS) System
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S018
- Product code
- NQO
- Decision date
- 2020-08-05
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval for a design and manufacturing change for an instrument component.
Current openFDA PMA Record#
- Device
- Superion Indirect Decompression (IDS) System
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S018
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2020-08-05
- Decision code
- APPR
- Date received
- 2020-06-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design and manufacturing change for an instrument component.