Definitions
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Etymologies
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Examples
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Riegel only applied to products in the strictest FDA tranche known as Premarket Approval products, which represent 1% to 2% of the overall medical device market.
Devices for Lawyers 2008
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This is known as Premarket Notification - also called PMN or 510 (k).
CAMLAW: Complementary and Alternative Medicine Law Blog 2010
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This is known as Premarket Notification - also called PMN or 510 (k).
CAMLAW: Complementary and Alternative Medicine Law Blog 2010
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Premarket approval rules require companies to submit clinical data and for the FDA to evaluate the data before deciding whether to approve a device.
Heart-Device Rules Reviewed Jennifer Corbett Dooren 2011
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Premarket educational inequalities are magnified by a labor market that increasingly rewards education.
Philip N. Cohen: What Ails Black Women, Part 1: Work and Wages 2009
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Under the reorganized structure, the direct line authority of the Director of the Office of Premarket Approval over most personnel reviewing petitions provides for more effective and efficient oversight of the process and allows for more uniform alignment of priorities.
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Premarket news Investors were struggling to look past Apple Inc.'s
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Premarket movers U.S. stock futures declined before the opening bell, but pared losses after the release of consumer-price data and a New York manufacturing gauge.
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Premarket news U.S. orders for durable goods rose 4% in July on strong demand for autos and commercial aircraft.
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Premarket movers U.S. stock futures indicated a lower open, as investors showed their disappointment with the latest corporate earnings results.
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