TPLC - Total Product Life Cycle

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Device	system, perfusion, kidney
Regulation Description	Isolated kidney perfusion and transport system and accessories.
Product Code	KDN
Regulation Number	876.5880
Device Class	2

Premarket Reviews
Manufacturer	Decision
BRIDGE TO LIFE
	SUBSTANTIALLY EQUIVALENT	3
BRIDGE TO LIFE, LTD.
	SUBSTANTIALLY EQUIVALENT	1
INSTITUT GEORGES LOPEZ
	SUBSTANTIALLY EQUIVALENT	1
INSTITUT GEROGES LOPEZ
	SUBSTANTIALLY EQUIVALENT	1
PARAGONIX TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	3
PARAGONIX TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRAGONIX TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT - KIT	1
S.A.L.F. SPA
	SUBSTANTIALLY EQUIVALENT	2
TRAFEROX TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
XVIVO PERFUSION AB
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	12	12
No Display/Image	2	2
Material Split, Cut or Torn	1	1
Device Markings/Labelling Problem	1	1
Defective Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Premature Discharge of Battery	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6	6
No Patient Involvement	5	5
No Consequences Or Impact To Patient	4	4
Insufficient Information	1	1