Superion Indirect Decompression System
FDA premarket approval P140004/S012 · decided 2018-03-26
Approval details
- PMA number
- P140004
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Superion Indirect Decompression System
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2017-12-15
- Decision date
- 2018-03-26
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.