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FDA Action on a PMA

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Premarket Approval of Medical Devices
  7. 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.

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