EON MINI AND PROGEGE IMPLANTABLE NEUROSTIMULATION DEVICE
FDA premarket approval P010032/S078 · decided 2014-07-07
Approval details
- PMA number
- P010032
- Supplement
- S078
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EON MINI AND PROGEGE IMPLANTABLE NEUROSTIMULATION DEVICE
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-04-08
- Decision date
- 2014-07-07
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- APPROVAL FOR UPDATING FIRMWARE FROM VERSION 3.0 TO VERSION 3.0.1 FOREON MINI (MODEL 3788) AND PROTÉGÉ (MODEL 2789) IMPLANTABLE PULSE GENERATOR THAT ARE USED IN SPINAL CORD STIMULATION THERAPY.
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