DevicePMAs@therightstef:P980053_S006 11 Projects
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Approval for a modified bead specification (90-212 um) for the pyrolytic carbon coated zirconium oxide and graphite beads. The device, as modified, will be marketed under the trade name durasphere exp and is indicated for use in the treatment of adult women with stress urinary incontinence (sui) due to intrinsic sphincter deficiency (isd).
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