PMA P030017S006

Device
PRECISION SPINAL CORD STIMULATOR SYSTEM
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S006
Product code
LGW
Decision date
2005-04-08
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE AN ALTERNATE SUPPLIER OF THE PRECISION SYSTEM LEAD AND LEAD EXTENSIONS.

Current openFDA PMA Record#

Device
PRECISION SPINAL CORD STIMULATOR SYSTEM
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S006
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2005-04-08
Decision code
OK30
Date received
2005-03-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE AN ALTERNATE SUPPLIER OF THE PRECISION SYSTEM LEAD AND LEAD EXTENSIONS.