Superion Indirect Decompression System
FDA premarket approval P140004/S009 · decided 2018-02-22
Approval details
- PMA number
- P140004
- Supplement
- S009
- 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
- 2017-08-28
- Decision date
- 2018-02-22
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for a manufacturing site located at Apex Tools & Orthopedics Company, 22 Xinzhuang Road 2,Yonghe, GETDD, Guangzhou 511356, China for manufacture of surgical 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.