GENESIS, GENESIS RC, GENESIS XP AND THE EON NEUROSTIMULATION SYSTEMS

FDA premarket approval P010032/S020 · decided 2007-06-11

Approval details

PMA number

P010032

Supplement

S020

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GENESIS, GENESIS RC, GENESIS XP AND THE EON NEUROSTIMULATION SYSTEMS

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2007-03-21

Decision date

2007-06-11

Days to decision

82 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

APPROVAL FOR THE USE OF THE TRIPOLE 8, TRIPOLE 8C, TRIPOLE 16C, AND EXCLAIM 8 LAMITRODE SERIES LEADS (MODELS 3208, 3210, 3214, 3224) WITH THE GENESIS, GENESIS RC, GENESIS XP, AND EON NEUROSTIMULATION SYSTEMS, WHICH ARE 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.

510(k) clearances by this applicant