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Number of total approvals by top pharmaceutical companies 2017

This statistic shows the number of total approvals from the top 10 pharmaceutical companies in 2017. During this year, Medtronic had a total of 791 approvals. A PMA (premarket approval) is a process undertaken by the FDA in the United States, to review and evaluate the safety and effectiveness of Class III medical devices. A traditional PMA application requires large volumes of information to be submitted such as device description and intended use, clinical studies, and labeling. The applicant is often the individual who owns the rights or has authorized access to the information required for submission.

Total number of approvals and clearances from top medical technology companies in 2017*

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Sources

Release date

September 2018

Region

United States

Survey time period

2017

Supplementary notes

* Including PMA/HDE/PDPs (premarket approvals, humanitarian device excemptions, etc.), 510(k)s (“substantially equivalent” to a legally marketed Class I, II, III device, where PMA not required).

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