SUPERION INTERSPINOUS SPACER SYSTEM
FDA premarket approval P140004/S003 · decided 2015-12-11
Approval details
- PMA number
- P140004
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SUPERION INTERSPINOUS SPACER SYSTEM
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Boston Scientific Neuromodulation
- Date received
- 2015-08-13
- Decision date
- 2015-12-11
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A CHANGE IN SUPPLIER OF THE FOLLOWING MANUAL INSTRUMENTS: P/N 100-9135, P/N 100-9146, P/N 100-9136, P/N 100-9137, P/N 100-9117, P/N 100-9127, AND P/N 100-9139.
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