PMA P040001S011

Device
X-STOP IPD SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
PMA number
P040001
Supplement
S011
Product code
NQO
Decision date
2009-01-14
Generic name
Prosthesis, spinous process spacer/plate
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
X-STOP IPD SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
PMA number
P040001
Supplement
S011
Product code
NQO
Generic name
Prosthesis, spinous process spacer/plate
Decision date
2009-01-14
Decision code
APPR
Date received
2008-06-26
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.