- Device
- Superion Indirect Decompression System
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S024
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2020-09-15
- Decision code
- APPR
- Date received
- 2020-08-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an alternate manufacturing site named Boston Scientific Limited located at Cashel Road, Clonmel, Ireland for sterile packaging and final packaging.