Chairman Waxman Requests Information about Medtronic's Sprint Fidelis Leads |
Today Chairman Waxman wrote to FDA requesting information about the Agency’s approval of Medtronic’s Sprint Fidelis leads, which are components used in implantable cardiac defibrillators. Medtronic voluntarily recalled the product after it was revealed that 2.3% of patients with the implanted leads would experience potentially life-threatening malfunctions. Documents and Links |
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