PMA P040001S012

Device: X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S012
Product code: NQO
Decision date: 2010-01-28
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: APPROVAL FOR A LABELING CHANGE TO ADD PLACEMENT OF THE PATIENT IN THE PRONE POSITION DURING IMPLANTATION OF THE DEVICE.

Current openFDA PMA Record#

Device: X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S012
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2010-01-28
Decision code: APPR
Date received: 2009-02-09
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING CHANGE TO ADD PLACEMENT OF THE PATIENT IN THE PRONE POSITION DURING IMPLANTATION OF THE DEVICE.