PMA P040001S009

Device: X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S009
Product code: NQO
Decision date: 2008-07-09
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: APPROVAL FOR THE REVISION OF THE PHYSICIAN GUIDES AND INSTRUCTIONS FOR USE TO CLARIFY THE CONDITIONS UNDER WHICH THE X-STOP MAY BE RE-STERILIZED AND TO PROVIDE REVISED AND MORE DETAILED INSTRUCTIONS REGARDING ATTACHMENT OF THE WING ASSEMBLY TO THE SPACER ASSEMBLY.

Current openFDA PMA Record#

Device: X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S009
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2008-07-09
Decision code: APPR
Date received: 2008-01-30
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE REVISION OF THE PHYSICIAN GUIDES AND INSTRUCTIONS FOR USE TO CLARIFY THE CONDITIONS UNDER WHICH THE X-STOP MAY BE RE-STERILIZED AND TO PROVIDE REVISED AND MORE DETAILED INSTRUCTIONS REGARDING ATTACHMENT OF THE WING ASSEMBLY TO THE SPACER ASSEMBLY.