The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPIEN 3 TRANSCATHETER HEART VALVE 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.
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Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN 3 TRANSCATHETER HEART VALVE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPIEN 3 TRANSCATHETER HEART VALVE and is publishing this notice of that det...
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83 FR 4224
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“Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN 3 TRANSCATHETER HEART VALVE,” thefederalregister.org (January 30, 2018), https://thefederalregister.org/documents/2018-01655/determination-of-regulatory-review-period-for-purposes-of-patent-extension-sapien-3-transcatheter-heart-valve.