| Device |
platelets, photochemical treatment system |
| Definition |
The photochemical treatment system is a class iii medical device for the preparation and storage of pathogen reduced donor derived platelets.The device has the process capability for the pathogen inactivation of platelets having platelet counts of 2.5-6.0x1011.The platelet products are indicated for support of patients requiring platelet transfusion according to clinical practice guidelines.There is no intended pharmacological effect attributed to residual amotosalen (s-59) in the platelet product. |
| Review Panel |
Hematology |
|---|
| Product Code | NJN |
|---|
| Submission Type |
Contact ODE
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
