PMA P140004S002

Device
SUPERION INTERSPINOUS SPACER
Applicant
Boston Scientific Neuromodulation
PMA number
P140004
Supplement
S002
Product code
NQO
Decision date
2015-12-15
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
SUPERION INTERSPINOUS SPACER
Applicant
Boston Scientific Neuromodulation
PMA number
P140004
Supplement
S002
Product code
NQO
Generic name
Prosthesis, spinous process spacer/plate
Decision date
2015-12-15
Decision code
APPR
Date received
2015-06-22
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.