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Technology / Center for Devices and Radiological Health / Unique Device Identification / Premarket approval / Medical device / Federal Food /  Drug /  and Cosmetic Act / Adverse event / Office of Regulatory Affairs / Mammography Quality Standards Act / Food and Drug Administration / Medicine / Health


2014 FDA Justification of Estimates for Appropriations Committees
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Company

CDRH / Artificial Pancreas Device Systems / Los Alamos Laboratories / /

Country

United States / /

Currency

USD / /

Event

Product Issues / FDA Phase / Business Partnership / /

Facility

Laboratory Science Service / /

IndustryTerm

upon current standards and systems / risk devices / certain devices / drug product / medical devices / robotic equipment / registry systems / manufacturing practice / principle systems / important medical devices / diagnostic products / medical device manufacturers / radiological drug products / radiation-emitting products / violative products / gel product / radiological products / information technology / implantable devices / internal communications / manufacturing capability / hazardous products / /

MedicalCondition

colorectal cancer / serious injury / end-stage renal disease / bacterial infections / disease / ESRD / /

MedicalTreatment

surgery / organ transplants / Radiation / /

Organization

Food and Drug Administration / office of Regulatory Affairs / Customs and Border Protection/Laboratory Science Service / Center for Devices / Medicare / White House / Radiological Health / FDA / Advisory Committee / /

Position

pilot continues / /

Product

Post-Approval Studies (PAS) / products / PMA Supplement / /

Technology

Radiation / X-ray / information technology / Tomography / diagnostic tests / ultrasound / microwave / MRI / /

URL

http /

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