EON CTM IPG NEUROSTIMULATION SYSTEM
FDA premarket approval P010032/S076 · decided 2014-04-25
Approval details
- PMA number
- P010032
- Supplement
- S076
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EON CTM IPG NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-01-10
- Decision date
- 2014-04-25
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- VAPPROVAL FOR PACKAGING MODIFICATIONS TO REMOVE THE MODEL 3009 TRIAL CABLE FROM APPROVED SJM LEADS AND EXTENSIONS.
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