Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | LIPOSORBER LA-15 SYSTEM |
Generic Name | Lipoprotein, low density, removal |
Applicant | KANEKA PHARMA AMERICA CORP. 546 FIFTH AVE., 21ST FLOOR NEW YORK, NY 10036 |
PMA Number | P910018 |
Supplement Number | S005 |
Date Received | 06/20/2000 |
Decision Date | 12/06/2000 |
Product Code |
MMY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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