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www.fdanews.com/articles/158980-fda-finalizes-guidance-on-electronic-source-data-in-clinical-trials

NeoTract Gets De Novo Clearance for First Permanent Implant for BPH

September 27, 2013
The FDA has cleared NeoTract’s UroLift system as the first permanent implant to relieve low or blocked urine flow in men 50 and older with an enlarged prostate. The UroLift device pulls back the prostate tissue that is pressing on the urethra, providing “a less invasive alternative to treating [benign prostatic hyperplasia] than surgery,” said Christy Foreman, director of the agency’s Office of Device Evaluation.
Devices & Diagnostics Letter