PMA P030017S019

Device: PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S019
Product code: LGW
Decision date: 2007-03-02
Classification: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: APPROVAL FOR UPDATES TO THE ?PHYSICIAN LEAD MANUAL? (FOR LINEAR LEADS AND EXTENSIONS) LABELING TO HELP MINIMIZE THE OCCURRENCE OF STYLET PENETRATION.

Current openFDA PMA Record#

Device: PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM
Applicant: Boston Scientific Corp
PMA number: P030017
Supplement: S019
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2007-03-02
Decision code: APPR
Date received: 2007-02-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR UPDATES TO THE ?PHYSICIAN LEAD MANUAL? (FOR LINEAR LEADS AND EXTENSIONS) LABELING TO HELP MINIMIZE THE OCCURRENCE OF STYLET PENETRATION.