PTK · Class III — High Risk (PMA approval required, life-sustaining) · Gastroenterology, Urology · 21 CFR 876.5980
Classification
FDA Product Code
PTK
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 876.5980
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
6
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
Definition
Lengthening atretic esophageal ends < 4cm apart and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. The procedure is performed with magnets inserted through an esophageal and gastric catheter.