PMA P030017S342

Device
Precision Montage and Precision Montage MRI Spinal Cord Stimulator Systems
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S342
Product code
LGW
Decision date
2020-09-30
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Change in the electrical resistance testing specification and an update to the supporting test equipment software.

Current openFDA PMA Record#

Device
Precision Montage and Precision Montage MRI Spinal Cord Stimulator Systems
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S342
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2020-09-30
Decision code
OK30
Date received
2020-08-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the electrical resistance testing specification and an update to the supporting test equipment software.