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  1. Development & Approval Process (CBER)

2020 Biological Device Application Approvals

This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance in reverse chronological order.

2020 Biological Device Application Approvals
Tradename/Common Name Description and Indication for Device Submission ID Manufacturer Clearance Date
PurePRP® SupraPhysiologic Concentrating System
Platelet and Plasma Separator for Bone Graft Handling
The PurePRP® SupraPhysiologic Concentrating System is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood at the patient's point of care. The PRP is mixed with autograft and allograft bone prior to application to an orthopedic surgical site to improve bone graft handling characteristics. BK190317/0 EmCyte Corporation
4331 Veronica S. Shoemaker Blvd., Suite 4
Fort Myers, FL 33916
02/12/2020
CompoMaster Net G5 Plus 9026551 CompoMat G5 Plus 9026561
Blood Bank Supplies
The CompoMat G5 Plus / CompoMaster Net G5 Plus System is intended as an automated blood component separator used for blood component separation and preparation. BK190413/0 Fresenius Kabi AG
Three Corporate Drive
Lake Zurich, Illinois 60047
02/06/2020
HemoMix 4 (Basic version) and HemoMix 4 (Internal optional RFID installed version)
Blood mixing devices and blood weighing devices
HemoMix 4 device is an automated blood monitor/mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the target volume has been reached. BK190429/0 Delcon S.R.L
Via Zanica, 19 F/I
24050 Grassobbio (BG)
Italy
01/30/2020
MATCH IT!® DNA (version 1.3)
Qualitative Test for HLA, Non-diagnostic
MATCH IT!® DNA Software is an accessory to aid in the evaluation of test results from Immucor GTI Diagnostics, Inc. LIFECODES HLA SSO kits for use with Luminex. Due to the complex nature of HLA Testing, qualified laboratory personnel must review any result to assure correctness. BK190439/0 Immucor GTI Diagnostics, Inc.
20925 Crossroads Circle
Waukeshaha, WI 53186
01/21/2020