PMA P140004S003

Device: SUPERION INTERSPINOUS SPACER SYSTEM
Applicant: Boston Scientific Neuromodulation
PMA number: P140004
Supplement: S003
Product code: NQO
Decision date: 2015-12-11
Classification: Prosthesis, Spinous Process Spacer/plate
Generic name: Prosthesis, spinous process spacer/plate
Approval order 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.

Current openFDA PMA Record#

Device: SUPERION INTERSPINOUS SPACER SYSTEM
Applicant: Boston Scientific Neuromodulation
PMA number: P140004
Supplement: S003
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2015-12-11
Decision code: APPR
Date received: 2015-08-13
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.