Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) 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 | S120 |
Date Received | 06/22/2016 |
Decision Date | 09/15/2016 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new optional accessory, the Lead and Extension Insertion Tool (Model 1803), for use with approved SJM Implantable Pulse Generators (IPGs) and compatible leads, extensions, and adapters. |
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