EON AND GENESIS RC NEUROSTIMULATION SYSTEMS
FDA premarket approval P010032/S019 · decided 2007-12-13
Approval details
- PMA number
- P010032
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EON AND GENESIS RC NEUROSTIMULATION SYSTEMS
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-01-23
- Decision date
- 2007-12-13
- Days to decision
- 689 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR INCREASING THE BATTERY LONGEVITY CLAIM FOR SEVEN YEARS TO 10 YEARS.
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