Premarket Device Notification

A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as a legally marketed device that is not subject to PMA (Premarket Authorization). (NCI Thesaurus)

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Premarket Device Application

A premarket submission made to FDA to review and evaluate the safety and effectiveness of a Class III medical device.

Premarket Approval Application

Stability data submitted for a PMA application.

Premalignant Hematologic Condition

A hematologic disorder which does not display the morphologic and/or clinical characteristics of an overt malignancy. Representative examples include atypical lymphoproliferative…

Premalignant Cell

Cells which show sign/s, that they can become cancerous.

Premalignant

A term used to describe a condition that may (or is likely to) become cancer. Also called precancerous.

Prelamin-A/C

Lamin-A/C protein (664 aa, ~74 kDa) is encoded by the human LMNA gene. This protein is involved in the framework required for…