| Device |
pediatric esophageal atresia anastomosis device |
| Regulation Description |
Gastrointestinal tube and accessories. |
| 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. |
| Physical State |
Plastic tubes, neodymium iron boron magnets |
| Technical Method |
Uses magnets advanced through esophageal and gastric catheters to bore through tissue and create an anastomosis. |
| Target Area |
Atretic esophageal ends |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | PTK |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
HDE - Humanitarian Device Exemption
|
|---|
| Regulation Number |
876.5980
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
