|
Device | EON MINI, PRODIGY AND BRIO CHARGING SYSTEMS |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S126 |
Date Received | 11/01/2016 |
Decision Date | 12/01/2016 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |