PMA P110008S003

Device
COFLEX INTERLAMINAR TECHNOLOGY
Applicant
Companion Spine France
PMA number
P110008
Supplement
S003
Product code
NQO
Decision date
2015-08-05
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
S003
Product code
NQO
Generic name
Prosthesis, spinous process spacer/plate
Decision date
2015-08-05
Decision code
APPR
Date received
2014-02-19
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.