EON MINI IPG NEUROSTIMULATION SYSTEM
FDA premarket approval P010032/S028 · decided 2009-03-19
Approval details
- PMA number
- P010032
- Supplement
- S028
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EON MINI IPG NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-01-08
- Decision date
- 2009-03-19
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR A MANUFACTURING SITE AT ST. JUDE MEDICAL PUERTO RICO, LLC, IN CAGUAS, PUERTO RICO.
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