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FDA Action on a PMA
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Medical Devices
Premarket Approval of Medical Devices
FDA Action on a PMA
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Section
814.40
Time frames for reviewing a PMA.
Section
814.42
Filing a PMA.
Section
814.44
Procedures for review of a PMA.
Section
814.45
Denial of approval of a PMA.
Section
814.46
Withdrawal of approval of a PMA.
Section
814.47
Temporary suspension of approval of a PMA.