Legal Opinion
Alabama Tissue Center of University of Alabama Health Service Foundation v. Sullivan
Court of Appeals for the Seventh Circuit
Decided September 16, 1992No. 91-2738PublishedCited by 2 opinions
1Opinion of the Court
SHABAZ, District Judge.
Six not-for-profit heart valve allograft processors filed a petition for review with this Court contesting the “Notice of Applicability of a Final Rule” (“NAFR”) published by the Food and Drug Administration (“FDA”) on June 26, 1991 at 56 Federal Register 29,177. The NAFR states that replacement heart valve allografts are subject to the final rule issued by the FDA on May 13, 1987, which requires the filing of a pre-market approval application (“PMA”) for all preamendment replacement heart valves and their equivalents. A heart valve allograft is a human heart valve…
2Cases cited22 opinions
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- Udall v. TallmanSupreme Court of the United States · 1965
- United States v. TurketteSupreme Court of the United States · 1981
- Griffin v. Oceanic Contractors, Inc.Supreme Court of the United States · 1982
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3Cited by2 opinions
- Alabama Tissue Center Of The University Of Alabama Health Service Foundation, P.C. v. Louis W. SullivanCourt of Appeals for the Seventh Circuit · 1992
- Arlette Parker, as Administrator of the Estate of Edward Parker v. United States of AmericaDistrict Court, N.D. Illinois · 2026