PMA P140004S005
- Device
- Superion® Indirect Decompression System (IDS)
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S005
- Product code
- NQO
- Decision date
- 2017-03-24
- Classification
- Prosthesis, Spinous Process Spacer/plate
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval for design modifications to the manual instrumentation used to implant the Superion® device.
Current openFDA PMA Record#
- Device
- Superion® Indirect Decompression System (IDS)
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S005
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2017-03-24
- Decision code
- APPR
- Date received
- 2017-01-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design modifications to the manual instrumentation used to implant the Superion® device.