Definition: Removal Of Plasma Components To Treat Focal Glomerulosclerosis
| Device Type ID | 2227 |
| Device Name | Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients |
| 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 Sep |
| 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 |
| Target Area | Plasma Components Are Removed To Aid The Patients Kidneys |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Renal Devices Branch (RNDB) |
| Submission Type | HDE - Humanitarian Device Exem |
| FDA Device Classification | Class HDE Medical Device |
| Product Code | PBN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2227 |
| Device | Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients |
| Product Code | PBN |
| Device Problems | |
|---|---|
Improper Or Incorrect Procedure Or Method | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 2 |