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Regulatory Information
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2019-09-11
article
Determination of Regulatory Review Period for Purposes of Patent Extension; Edwards Pericardial Aortic Bioprosthesis
Notices
D09002ee1bdb6d330
D09002ee1bdb6d399
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (Models 11000A and 11500A) 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.
84 FR 47960
https://www.govinfo.gov/app/details/FR-2019-09-11/2019-19600
2019-19600
fr11se19-61
4164-01-P
Docket Nos. FDA-2018-E-0298
FDA-2018-E-0299
FDA-2018-E-0301
and FDA-2018-E-0321
https://www.govinfo.gov/app/details/FR-2019-09-11/2019-19600
https://www.govinfo.gov/content/pkg/FR-2019-09-11/html/2019-19600.htm
https://www.govinfo.gov/content/pkg/FR-2019-09-11/pdf/2019-19600.pdf
3 p.
47960
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84 FR 47960
Determination of Regulatory Review Period for Purposes of Patent Extension; Edwards Pericardial Aortic Bioprosthesis; Federal Register Vol. 84, Issue
NOTICE
2019-19600
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2020-03-09
Docket Nos. FDA-2018-E-0298
FDA-2018-E-0299
FDA-2018-E-0301
and FDA-2018-E-0321
4164-01-P
2019-19600
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (Models 11000A and 11500A) 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.
Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by November 12, 2019. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by March 9, 2020. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more information.
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
Determination of Regulatory Review Period for Purposes of Patent Extension:
Edwards Pericardial Aortic Bioprosthesis
,
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 176
Office of the Federal Register, National Archives and Records Administration
2019-09-11
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176 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-09-11
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0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr11se19
https://www.govinfo.gov/app/details/FR-2019-09-11
https://www.govinfo.gov/content/pkg/FR-2019-09-11/pdf/FR-2019-09-11.pdf
https://www.govinfo.gov/content/pkg/FR-2019-09-11/xml/FR-2019-09-11.xml
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2019-09-11
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FR-2019-09-11
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FR-2019-09-11
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176