PMA P140004S022
- Device
- Superion Indirect Decompression System
- Applicant
- Boston Scientific Neuromodulation
- Product code
- NQO
- Decision date
- 2020-09-17
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Addition of an injection molding process for instrument manufacture.
Current openFDA PMA Record#
- Device
- Superion Indirect Decompression System
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S022
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2020-09-17
- Decision code
- OK30
- Date received
- 2020-08-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an injection molding process for instrument manufacture.