•  11/3/2020 07:52 AM

A premarket approval (PMA) application is the most stringent type of device marketing application for medical devices.

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  •  11/3/2020 06:19 AM

Examples of medical devices include surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. A longer list of examples of medical devices is in the FDA Information Sheet Guidance, “Significant Risk vs. Non-Significant Risk Devices.”

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