PMA P140004S027
- Device
- Superion Indirect Decompression System
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S027
- Product code
- NQO
- Decision date
- 2022-02-08
- Generic name
- Prosthesis, spinous process spacer/plate
- Approval order statement
- Approval for the sterilization site change have been reviewed and are acceptable.
Current openFDA PMA Record#
- Device
- Superion Indirect Decompression System
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S027
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2022-02-08
- Decision code
- APPR
- Date received
- 2021-12-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the sterilization site change have been reviewed and are acceptable.