- Device
- Superion Indirect Decompression System
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S012
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2018-03-26
- Decision code
- APPR
- Date received
- 2017-12-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Model Solution Co, Ltd, 24, Beottkot-ro 20-gil, Geumcheogu, Seoul, Republic of Korea for manufacture of instrumentation.