Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (P910023/S295 and P030054/S223)

Mon, 09/17/2012 - 12:00am
U.S. Food & Drug Administration

Representation of transparency with a photo of two hands holding a transparent window frame in a blue sky with white clouds.

For many years, FDA's Center for Devices and Radiological Health (CDRH) has provided information to help industry comply with FDA regulations.

In support of the FDA Transparency Initiative, CDRH is providing additional information to help the public understand its processes and decisions. The new information includes:

  • information about regulatory decisions and the rationales for those decisions
  • descriptions of regulatory processes
  • data to support CDRH actions and public health activities


The list below contains information that CDRH is releasing for the first time. The additional pages on this Web site provide information about CDRH processes and decisions.


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