ANS EON C (IPG) NEUROSTIMULATION SYSTEM
FDA premarket approval P010032/S021 · decided 2007-12-10
Approval details
- PMA number
- P010032
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANS EON C (IPG) NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2007-07-13
- Decision date
- 2007-12-10
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR THE USE OF THE ANS EONC (IPG) NEUROMODULATION SYSTEM, MODEL 3688 WHICH IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC PAIN OF THE TRUNK AND/OR LIMB, INCLUDING UNILATERAL AND BILATERAL PAIN ASSOCIATED WITH ANY OF THE FOLLOWING: FAILED BACK SURGERY SYNDROME, AND INTRACTABLE LOW BACK AND LEG PAIN.
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