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Esophageal Dilator Balloon With Or Without Electrode Sensors

FDA product code PID · 3 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.5980
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-03-11 – 2019-01-25

To dilate the lower esophageal sphincter of patients with Achalasia.

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