Genesis Neurostimulation System
FDA premarket approval P010032/S150 · decided 2019-07-15
Approval details
- PMA number
- P010032
- Supplement
- S150
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Genesis Neurostimulation System
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-05-07
- Decision date
- 2019-07-15
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval to add Midwest Sterilization Corporation, 1204 Lenco Avenue, Jackson, Missouri, as an alternate ethylene oxide sterilization site for numerous neuromodulation products.
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