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The current post-market, prospective, multi-center study evaluated the safety and IOP-lowering efficacy of two GTS-400 inject inject devices implanted as a sole procedure.
In all except one, the method of evacuation was surgical, either as a sole procedure or by misoprostol 800 μg vaginally.
To our knowledge, this is the first prospective multi-centered study of iStent inject implantation as the sole procedure in eyes with open-angle glaucoma.
Micro-invasive glaucoma surgical implantation of trabecular micro-bypass stents, previously shown to be safe and effective for open-angle glaucoma (OAG) subjects during cataract surgery, was considered for evaluation as a sole procedure.
This report summarizes data from patients who underwent implantation of the second generation GTS-400 inject inject device via either the Model G2-0 injector or the Model G2-M-IS Injector as a sole procedure.
Furthermore, the IOP-lowering effect of two iStent inject devices implanted as a sole procedure in this study appears to be greater than that of a single iStent implanted in conjunction with cataract surgery.
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The House Report is to the same effect, stating that the prescribed deportation proceedings shall be the sole and exclusive procedure, 'notwithstanding the provisions of any other law.' H.R.Rep.
Section 242(b) expressly states: 'The procedure (herein prescribed) shall be the sole and exclusive procedure for determining the deportability of an alien under this section.' That this clear and categorical direction was meant to exclude the application of the Administrative Procedure Act is amply demonstrated by the legislative history of the Immigration Act.
961, 'shall apply to, and shall be the sole and exclusive procedure for, the judicial review of all final orders of deportation heretofore or hearafter made against aliens * * * pursuant to administrative proceedings under section 242(b) of this Act * * *.' These procedures vest in the courts of appeals exclusive jurisdiction to review final orders issued by specified federal agencies.
The provision was that 'Notwithstanding any other law, including the Act of June 11, 1946 (the Administrative Procedure Act), the proceedings so prescribed shall be the sole and exclusive procedure for determining the deportability of an alien who is in the United States'.
The District Court dismissed the action on the ground that, under the recently enacted § 106(a) of the Immigration and Nationality Act, 8 U.S.C. 1105a(a), 2 the sole and exclusive procedure for obtaining judicial review of such a determination was by a petition for review filed in an appropriate Federal Court of Appeals.
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