GENESIS, GENESIS RC AND THE EON NEUROSTIMULATION SYSTEMS
FDA premarket approval P010032/S018 · decided 2005-12-21
Approval details
- PMA number
- P010032
- Supplement
- S018
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GENESIS, GENESIS RC AND THE EON NEUROSTIMULATION SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-11-25
- Decision date
- 2005-12-21
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR THE 90 CM AND 110 CM LENGTH VERSIONS OF THE ANS 3100 AND 3200 SERIES LEADS, 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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