EON IMPLANTABLE PULSE GENERATOR (IPG) NEUROSTIMULATION SYSTEM
FDA premarket approval P010032/S032 · decided 2010-04-08
Approval details
- PMA number
- P010032
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EON IMPLANTABLE PULSE GENERATOR (IPG) NEUROSTIMULATION SYSTEM
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-07-15
- Decision date
- 2010-04-08
- Days to decision
- 267 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR THE INCORPORATION OF A COLOR ADDITIVE TO CHANGE THE COLOR OF THE POCKET SIZER TO YELLOW, SO THAT IT WOULD BE MORE EASILY VISIBLE TO THE PHYSICIAN.
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