Search Results

The AMT Transgastric-Jejunal feeding tube is indicated for use in patients who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy. The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

Not Found

The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Applied Medical Technology, Inc., regarding their "AMT Low-Profile Transgastric-Jejunal Feeding Tube Kit."

The letter acknowledges receipt of their submission, informs them that the device has been determined to be substantially equivalent to a legally marketed predicate device, and outlines regulatory responsibilities. It also states the indications for use and contraindications for the device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study that proves the device meets them based on the provided input.

Ask a specific question about this device