PMA P030017S235

Device
PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM, PRECISION MONTAGE SPINAL CORD STIMULATOR SYSTEM
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S235
Product code
LGW
Decision date
2016-04-28
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
addition of the PrecisionTM MontageTM MRI and PrecisionTM MontageTM System Components

Current openFDA PMA Record#

Device
PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM, PRECISION MONTAGE SPINAL CORD STIMULATOR SYSTEM
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S235
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2016-04-28
Decision code
APPR
Date received
2015-09-10
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
addition of the PrecisionTM MontageTM MRI and PrecisionTM MontageTM System Components