🩺FDA Patent Extension Determination for EDWARDS SAPIEN 3 ULTRA RESILIA
Determination of Regulatory Review Period for Purposes of Patent Extension; [EDWARDS SAPIEN 3 ULTRA RESILIA-PMA 140031 S-141]
Summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EDWARDS SAPIEN 3 ULTRA RESILIA premarket approval application (PMA) 140031 supplement (S-141) 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
$$$ - High
The regulatory determination for the EDWARDS SAPIEN 3 ULTRA RESILIA’s patent extension has direct effects on companies seeking patent term restorations, impacting market exclusivity and competitive advantage. Compliance with submission timelines and regulations by FDA and USPTO is crucial for affected businesses.