PMA P030017S140

Device
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S140
Product code
LGW
Decision date
2012-10-01
Classification
Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
APPROVAL FOR MINOR PACKAGING DESIGN CHANGES TO THE INNER TRAY AND INNER TRAY COVER FOR THE PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM IMPLANTABLE PULSE GENERATOR (IPG) KITS.

Current openFDA PMA Record#

Device
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM
Applicant
Boston Scientific Corp
PMA number
P030017
Supplement
S140
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2012-10-01
Decision code
APPR
Date received
2012-08-07
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MINOR PACKAGING DESIGN CHANGES TO THE INNER TRAY AND INNER TRAY COVER FOR THE PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM IMPLANTABLE PULSE GENERATOR (IPG) KITS.