EON NEUROSTIMULATION (IPG), ANS EON C NEUROSTIMULATION (IPG), AND EON MINI NEUROSTIMULATION(IPG)
FDA premarket approval P010032/S029 · decided 2009-06-01
Approval details
- PMA number
- P010032
- Supplement
- S029
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EON NEUROSTIMULATION (IPG), ANS EON C NEUROSTIMULATION (IPG), AND EON MINI NEUROSTIMULATION(IPG)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-04-02
- Decision date
- 2009-06-01
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR PENTA LEAD KITS (MODELS 3227, 3228, 3229, 3230, 3231, 3232, 3233, AND 3234).
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