Device |
aspiration therapy system |
Definition |
Percutaneous gastric implant to remove stomach contents after eating for weight loss in the treatment of obesity in adults |
Physical State |
PEG tube made of plastic |
Technical Method |
percutaneous implantation |
Target Area |
stomach |
Review Panel |
Gastroenterology/Urology |
Product Code | OYF |
Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
Submission Type |
PMA
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|