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 | Prodigy Leads and Extension Insertion Tool |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S124 |
Date Received | 10/11/2016 |
Decision Date | 01/09/2017 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for expanding the compatibility of an 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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