- Device
- Superion Indirect Decompression System (IDS)
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S017
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2020-07-22
- Decision code
- APPR
- Date received
- 2020-05-13
- 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, named Synergy Health Westport, a STERIS Company, located at Lodge Road, Westport, Co. Mayo, Ireland for sterilization.