Precision Spinal Cord Stimulation(Scs) System

FDA premarket approval P030017 · Stimulator, spinal-cord, totally implanted for pain relief

PMA numberP030017

Approval

Applicant
Boston Scientific Corp
Received
May 14, 2003
Decision date
April 27, 2004 (APPR)
Supplements
372, latest September 9, 2026
Product code
LGW – Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Official FDA PMA record

Approval order statement

APPROVAL FOR THE PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM. THE DEVICE IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH THE FOLLOWING: FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.