PMA P110008S001

Device
COFLEX® INTERLAMINAR TECHNOLOGY
Applicant
Companion Spine France
PMA number
P110008
Supplement
S001
Product code
NQO
Decision date
2013-04-23
Classification
Prosthesis, Spinous Process Spacer/plate
Generic name
Prosthesis, spinous process spacer/plate
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
COFLEX® INTERLAMINAR TECHNOLOGY
Applicant
Companion Spine France
PMA number
P110008
Supplement
S001
Product code
NQO
Generic name
Prosthesis, spinous process spacer/plate
Decision date
2013-04-23
Decision code
APPR
Date received
2012-11-26
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.