PMA P010032S078
- Device
- EON MINI AND PROGEGE IMPLANTABLE NEUROSTIMULATION DEVICE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S078
- Product code
- LGW
- Decision date
- 2014-07-07
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order 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.
Current openFDA PMA Record#
- Device
- EON MINI AND PROGEGE IMPLANTABLE NEUROSTIMULATION DEVICE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S078
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2014-07-07
- Decision code
- APPR
- Date received
- 2014-04-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.