EON NEUROSTIMULATION SYSTEM
FDA premarket approval P010032/S059 · decided 2013-01-09
Approval details
- PMA number
- P010032
- Supplement
- S059
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EON NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-07-17
- Decision date
- 2013-01-09
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL THE REVISION TO THE MANUFACTURING PROCESS FOR EON MINI (MODEL 3788) IMPLANTABLE PULSE GENERATOR HEADERS.
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