GENESIS NEUROSTIMULATION SYSTEM
FDA premarket approval P010032/S012 · decided 2004-11-09
Approval details
- PMA number
- P010032
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GENESIS NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2004-05-10
- Decision date
- 2004-11-09
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR THE GENESIS RC NEUROSTIMULATION SYSTEM, MODEL 3708, AND THE GENESIS RC DUAL (IPG) SYSTEM, MODEL 3744, 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.
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