EON MINI IPG NEUROSTIMULATION SYSTEM

FDA premarket approval P010032/S058 · decided 2012-09-14

Approval details

PMA number

P010032

Supplement

S058

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

EON MINI IPG NEUROSTIMULATION SYSTEM

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2012-07-16

Decision date

2012-09-14

Days to decision

60 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

APPROVAL FOR THE MODIFICATION TO THE MODEL 3721 EON MINI CHARGINGSYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MODEL 3720 EON MINI LE CHARGER AND MODEL 3722 EON MINI LE CHARGING SYSTEM AND IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL PAIN ASSOCIATED WITH ANY OF THE FOLLOWING: FAILED BACK SURGERY SYNDROME, AND CHRONIC LOW BACK/LEG PAIN.

510(k) clearances by this applicant