PMA P010032S126
- Device
- EON MINI, PRODIGY AND BRIO CHARGING SYSTEMS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S126
- Product code
- LGW
- Decision date
- 2016-12-01
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Outsource the supply of an electronic wire component in the device assembly to a new supplier Carlisle Interconnect Technologies for various external devices with a change in the wire strip length at the tolerance level.
Current openFDA PMA Record#
- Device
- EON MINI, PRODIGY AND BRIO CHARGING SYSTEMS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P010032
- Supplement
- S126
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2016-12-01
- Decision code
- OK30
- Date received
- 2016-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Outsource the supply of an electronic wire component in the device assembly to a new supplier Carlisle Interconnect Technologies for various external devices with a change in the wire strip length at the tolerance level.