SCHULTHEIS, Acting Chief Judge.
The Medical Device Amendments of 1976(MDA) to the Federal Food, Drug and Cosmetic Act established a federal approval process for the manufacture of new medical devices. One such device, the Angelchik Anti-Reflux Prosthesis, was surgically implanted in Adeline Wutzke. Her suit against the device's manufacturer for negligent design and manufacture was dismissed on summary judgment.
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