GENESIS NEUROSTIMULATION (IPG) SYSTEM

FDA premarket approval P010032/S009 · decided 2004-01-20

Approval details

PMA number

P010032

Supplement

S009

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

GENESIS NEUROSTIMULATION (IPG) SYSTEM

Generic name

Stimulator, spinal-cord, totally implanted for pain relief

Applicant

ABBOTT MEDICAL

Date received

2003-11-12

Decision date

2004-01-20

Days to decision

69 days

Decision code

APPR

Product code

LGW

Advisory committee

Neurology

Expedited review

No

Location

Plano, TX

Statement

APPROVAL FOR THE USE OF THE AXXESS PERCUTANEOUS LEAD MODELS 4143, 4146, 4153 AND 4156 WITH THE ANS GENESIS NEUROSTIMULATION (IPG) MODEL 3608, THE ANS GENESIS XP NEUROSTIMULATION (IPG) MODEL 3609, THE ANS GENESIS DUAL XP NEUROSTIMULATION (IPG) MODEL 3644 AND THE ANS GENESIS G4 NEUROSTIMULATION (IPG) MODEL 3604 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, I

510(k) clearances by this applicant