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MAY 2009 VOL. 98, NO. 5POLISH AMERICAN JOURNAL MAY $20092.00Established 1911www.polamjournal.dedicated TO THE PROMOTION AND CONTINUANCE OF POLISH AMERICAN CULTUREPERIODICAL POSTAGE PAID AT BOSTON,
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Individuals or organizations who are applying for a Product Marketing Authorization (PMA) may need to fill out the form PMA.
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Form PMA is a submission to the FDA for premarket approval of medical devices.
Manufacturers seeking to market medical devices in the U.S. that require premarket approval.
Form PMA can be filled out and submitted electronically through the FDA's eSubmitter system.
The purpose of Form PMA is to demonstrate the safety and effectiveness of the medical device.
Form PMA requires detailed information on the medical device, preclinical and clinical data, manufacturing processes, and labeling.
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