← REGULATORY CHANGES
FEDERAL REGISTER · NOTICEFebruary 29, 2024NOTICE — NO LEGAL EFFECT

Determination of Regulatory Review Period for Purposes of Patent Extension; AMPLATZER AMULET

What this record is not

Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSEAug 27, 2024 · closed
APPLIES TO · SPEQ TAGDevice
Document type
Notice
Agency
Health and Human Services Department
Published
February 29, 2024
Comments close
August 27, 2024
Document number
2024-04206
Docket
FDA-2022-E-0661, FDA-2022-E-0665, FDA-2022-E-0667, FDA-2022-E-0670
ABSTRACT

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AMPLATZER AMULET 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 patents which claims that medical device.

Abstract as published in the Federal Register.

READ THE FULL DOCUMENT

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.

View on federalregister.gov →

That is what FDA published. A free account files it on your watchlist and sends one weekly email with whatever lands next.

Create a free account