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PMA P910018S005

Device
LIPOSORBER LA-15 SYSTEM
Applicant
Kaneka Pharma America Corp.
PMA number
P910018
Supplement
S005
Product code
MMY
Decision date
2000-12-06
Classification
Lipoprotein, Low Density, Removal
Generic name
Lipoprotein, low density, removal
Approval order statement
APPROVAL FOR 1) REPLACING THE STERILIZATION DATE WITH THE ACTUAL EXPIRATION DATE, EXPRESSED AS MONTH AND YEAR, FOR THE LIPOSORBER(R) LA-15 SYSTEM COMPONENTS: LIPOSORBER(R) LA-15 COLUMN, SULFLUX(R) FS-05 PLASMA SEPARATOR, AND THE TUBING SYTEM FOR PLASMAPHERESIS LT-MA2; 2) REPLACING THE SLIP-TYPE MALE TUBING CONNECTORS WITH LUER-LOCK TYPE CONNECTORS ON THE SEPARATOR END-CAPS OF TE SULFLUX FS-05 PLASMA SEPARATOR; 3) MAKING THE FOLLOWING CHANGES TO THE TUBING SYSTEM FOR THE PLASMAPHERESIS LT-MA2: A) PROVIDING STERILE TRANSDUCER PROTECTIVE FILTERS (FOUND SUBSTANTIALLY EQUIVALENT UNDER 510(K) K983076) IN PACKAGES OF TEN; B) REDUCING THE NUMBER OF CONNECTION TUBES FROM TEN TO EIGHT, ADDING PINCH CLIPS AND REDUCING THE SHARPNESS OF THE PLASTIC SPIKE ON EACH END OF THE CONNECTION TUBE; C) REPLACING THE STAINLESS STEEL NEEDLES, USED TO CONNECT EACH INFUSION LINE TO A BAG OR BOTTLE OF SALINE OR REGENERATION FLUID, WITH PLASTIC SPIKES; D) ADDING A LUER-LOCK "MALE" AND "FEMALE" CONNECTOR TO THE END OF THE WASTE LINES; E) INCREASING THE LENGTH OF THE TUBING SECTION BETWEEN THE BLOOD PUMP AND CHANBER LEVEL 1 FROM 80 MM TO 90 MM AND THE LENGTH OF THE TUBING SECTION BETWEEN THE WASTE DRIP CHAMBER AND A "T" DCONNECTOR ON THE WASTE LINE FROM 35 M TO 50 MM; AND F) ADDING AN INFUSION LINE.

Current openFDA PMA Record#

Device
LIPOSORBER LA-15 SYSTEM
Applicant
Kaneka Pharma America Corp.
PMA number
P910018
Supplement
S005
Product code
MMY
Generic name
Lipoprotein, low density, removal
Decision date
2000-12-06
Decision code
APPR
Date received
2000-06-20
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR 1) REPLACING THE STERILIZATION DATE WITH THE ACTUAL EXPIRATION DATE, EXPRESSED AS MONTH AND YEAR, FOR THE LIPOSORBER(R) LA-15 SYSTEM COMPONENTS: LIPOSORBER(R) LA-15 COLUMN, SULFLUX(R) FS-05 PLASMA SEPARATOR, AND THE TUBING SYTEM FOR PLASMAPHERESIS LT-MA2; 2) REPLACING THE SLIP-TYPE MALE TUBING CONNECTORS WITH LUER-LOCK TYPE CONNECTORS ON THE SEPARATOR END-CAPS OF TE SULFLUX FS-05 PLASMA SEPARATOR; 3) MAKING THE FOLLOWING CHANGES TO THE TUBING SYSTEM FOR THE PLASMAPHERESIS LT-MA2: A) PROVIDING STERILE TRANSDUCER PROTECTIVE FILTERS (FOUND SUBSTANTIALLY EQUIVALENT UNDER 510(K) K983076) IN PACKAGES OF TEN; B) REDUCING THE NUMBER OF CONNECTION TUBES FROM TEN TO EIGHT, ADDING PINCH CLIPS AND REDUCING THE SHARPNESS OF THE PLASTIC SPIKE ON EACH END OF THE CONNECTION TUBE; C) REPLACING THE STAINLESS STEEL NEEDLES, USED TO CONNECT EACH INFUSION LINE TO A BAG OR BOTTLE OF SALINE OR REGENERATION FLUID, WITH PLASTIC SPIKES; D) ADDING A LUER-LOCK "MALE" AND "FEMALE" CONNECTOR TO THE END OF THE WASTE LINES; E) INCREASING THE LENGTH OF THE TUBING SECTION BETWEEN THE BLOOD PUMP AND CHANBER LEVEL 1 FROM 80 MM TO 90 MM AND THE LENGTH OF THE TUBING SECTION BETWEEN THE WASTE DRIP CHAMBER AND A "T" DCONNECTOR ON THE WASTE LINE FROM 35 M TO 50 MM; AND F) ADDING AN INFUSION LINE.