EON IMPLANTED PULSE GENERATOR (IPG) SYSTEM
FDA premarket approval P010032/S036 · decided 2011-02-11
Approval details
- PMA number
- P010032
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EON IMPLANTED PULSE GENERATOR (IPG) SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-11-23
- Decision date
- 2011-02-11
- Days to decision
- 80 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR ADDING HEAT SHRINK TUBING (HST) TO THE CONDUCTORS OF THE COAXIAL CABLE OF THE CHARGING ANTENNA WHICH IS USED WITH THE EON IPG SYSTEM.
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