EON NEUROSTIMULATION SYSTEM
FDA premarket approval P010032/S055 · decided 2012-10-25
Approval details
- PMA number
- P010032
- Supplement
- S055
- 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
- 2012-06-06
- Decision date
- 2012-10-25
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR THE ADDITION OF STAND-OFF TABS ON THE ROUTED PRINTED CIRCUIT BOARD (PCB), TO CHANGE THE EQUIPMENT USED TO ROUTE THE PCBS, AND TO ADD KAPTON TAPE TO THE BATTERY SURFACE TO PREVENT CONTACT WITH COPPER TRACES FROM THE PCB AND THE ADJACENT SURFACE OF THE BATTERY.
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