EON MINI IMPLANTABLE PULSE GENERATOR
FDA premarket approval P010032/S066 · decided 2013-03-15
Approval details
- PMA number
- P010032
- Supplement
- S066
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EON MINI IMPLANTABLE PULSE GENERATOR
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-12-26
- Decision date
- 2013-03-15
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE HEADER OF EON MINI IMPLANTABLEPULSE GENERATOR (IPG), MODEL 3788.
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