PMA P040001S008

Device: X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S008
Product code: NQO
Decision date: 2007-12-14
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT KYPHON, INC., SUNNYVALE, CALIFORNIA, FOR INSPECTION, PACKAGING AND FINAL ACCEPTANCE.

Current openFDA PMA Record#

Device: X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Applicant: Medtronic Sofamor Danek, Inc.
PMA number: P040001
Supplement: S008
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2007-12-14
Decision code: APPR
Date received: 2007-10-26
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT KYPHON, INC., SUNNYVALE, CALIFORNIA, FOR INSPECTION, PACKAGING AND FINAL ACCEPTANCE.