DevicePMAs@therightstef:P970008_S006 / 250-256 JSONTXT

Approval for an expansion of the indication for use statement to include relief o obstruction. The indication for use, as modified, is "The Urologix Targis System is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethra lengths of 30 to 50 mm.

projects that have annotations to this span

Unselected / annnotation Selected / annnotation
PMA_MER 1 (1)