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Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters; Availability

September 8, 2010 by admin

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls).

Center for Scientific Review; Notice of Closed Meetings

September 8, 2010 by admin

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls).

Notice of a Meeting of a Working Group of the NIH Blue Ribbon Panel

September 8, 2010 by admin

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls).

National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting

September 8, 2010 by admin

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls).

National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting

September 8, 2010 by admin

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls).

Center for Scientific Review; Notice of Closed Meetings

September 8, 2010 by admin

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls).

National Heart, Lung, and Blood Institute; Notice of Closed Meeting

September 8, 2010 by admin

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls).

National Eye Institute; Notice of Meeting

September 8, 2010 by admin

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.'' The guidance was developed as a special control to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls).

Privacy Act of 1974; United States Citizenship and Immigration Services-012 Citizenship and Immigration Data Repository System of Records

September 8, 2010 by admin

In accordance with the Privacy Act of 1974, the Department of Homeland Security proposes to establish a new Department of Homeland Security system of records notice titled, ``DHS U.S. Citizenship and Immigration Services 012 Citizenship and Immigration Data Repository System of Records.'' Citizenship and Immigration Data Repository is a mirror copy of USCIS's major immigrant and non-immigrant benefits databases combined into a single user interface and presented in an updated, searchable format on the classified network.

Agency Information Collection Activities: Form I-914; Extension of an Existing Information Collection; Comment Request

September 8, 2010 by admin

In accordance with the Privacy Act of 1974, the Department of Homeland Security proposes to establish a new Department of Homeland Security system of records notice titled, ``DHS U.S. Citizenship and Immigration Services 012 Citizenship and Immigration Data Repository System of Records.'' Citizenship and Immigration Data Repository is a mirror copy of USCIS's major immigrant and non-immigrant benefits databases combined into a single user interface and presented in an updated, searchable format on the classified network.

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