PMA P040001

Device: X-STOP LTOS
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S021
Product code: NQO
Decision date: 2014-12-12
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: APPROVAL FOR AN UPDATE TO THE X STOP® INTERSPINOUS SPACER SYSTEM LABELING TO REFLECT THE RESULTS FROM THE LONG TERM OUTCOMES STUDY (LTOS) THAT WAS CONDUCTED AS A POSTAPPROVAL STUDY REQUIREMENT.

Current openFDA PMA Record#

Device: X-STOP LTOS
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S021
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2014-12-12
Decision code: APPR
Date received: 2013-08-05
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: APPROVAL FOR AN UPDATE TO THE X STOP® INTERSPINOUS SPACER SYSTEM LABELING TO REFLECT THE RESULTS FROM THE LONG TERM OUTCOMES STUDY (LTOS) THAT WAS CONDUCTED AS A POSTAPPROVAL STUDY REQUIREMENT.