PMA P040001S001

Device
X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
PMA number
P040001
Supplement
S001
Product code
NQO
Decision date
2006-12-08
Generic name
Prosthesis, spinous process spacer/plate
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY.

Current openFDA PMA Record#

Device
X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Applicant
Medtronic Sofamor Danek, Inc.
PMA number
P040001
Supplement
S001
Product code
NQO
Generic name
Prosthesis, spinous process spacer/plate
Decision date
2006-12-08
Decision code
APPR
Date received
2006-01-23
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY.