EON C (IPG) NEUROSTIMULATION SYSTEM
FDA premarket approval P010032/S040 · decided 2011-08-12
Approval details
- PMA number
- P010032
- Supplement
- S040
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EON C (IPG) NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-07-18
- Decision date
- 2011-08-12
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR LABELING CHANGES TO INCLUDE ADDITIONAL INFORMATION REGARDING BATTERY PASSIVATION IN THE EON C IPG DIRECTIONS FOR USE.
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