| Device |
apheresis for focal glomerulosclerosis in adult and pediatric patients |
| Definition |
Removal of plasma components to treat focal glomerulosclerosis |
| Physical State |
Composed of four components: a pair of paheresis columns (dextran sulfate cellulose adsorption column soaked in sodium citrate solution); two other disposable components (a hollow fiber, ethylene vinyl alcohol copolymer-coated polyethylene plasma separator and a polyvinyl chloride tubing system); and a reusable electronic control unit. |
| Technical Method |
Blood is pumped from patients arm into the device which then separates blood into cellular components and plasma. Plasma is then sent thru dextran sulfate cellulose column to remove specific plasma components. Depleted plasma is then recombined with cellular blood elements and is then pumped back to patient. |
| Target Area |
Plasma components are removed to aid the patients kidneys |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | PBN |
|---|
| 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
|
|---|
| Device Class |
HDE
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
