🏥FDA Review Period Determination for Impella RP Flex Medical Device
Determination of Regulatory Review Period for Purposes of Patent Extension; [IMPELLA RP FLEX WITH SMART ASSIST]
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for IMPELLA RP FLEX WITH SMART ASSIST and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The text discusses the FDA’s determination of a regulatory review period for the IMPELLA RP FLEX WITH SMART ASSIST medical device, essential for patent extension applications. Compliance with FDA regulations and the potential for patent term restoration influence business strategies, particularly for firms in the medical device sector.