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PMA |
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The device, a heart pump, was subject to extensive scrutiny by the FDA during its premarket approval (PMA) process, wrote Judge Leonard Garth, who, along with Judge Thomas Ambro, found that a lower court correctly dismissed the suit because its common law claims would conflict with the federal requirements of that process. On March 25, 2004 the FDA's General and Plastic Surgery Devices Panel will hold a public hearing on "a premarket approval application (PMA) for an injectable device intended for use in the correction of In January 2001, the FDA approved a Premarket Approval (PMA) application supplement requesting removal of the neurosurgical labeling limitation for use of Proceed. |
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