Genesis and Eon Family Neurostimulation (Ipg) Systems

FDA premarket approval P010032 · Stimulator, spinal-cord, totally implanted for pain relief

PMA numberP010032

Approval

Applicant
Abbott Medical
Received
May 29, 2001
Decision date
November 21, 2001 (APPR)
Supplements
242, latest September 11, 2026
Product code
LGW – Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Official FDA PMA record

Approval order statement

APPROVAL FOR THE GENESIS NEUROSTIMULATION (IPG) SYSTEM. THE SYSTEM INCLUDES THE FOLLOWING COMPONENTS: THE MODEL 3608 PULSE GENERATOR, THE MODEL 3850 PATIENT PROGRAMMER, THE MODEL 1232 PROGRAMMING WAND AND THE MODEL 1210 PATIENT MAGNET. 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 FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.