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(R) 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 | S021 |
Date Received | 07/29/2016 |
Decision Date | 10/14/2016 |
Product Code |
MMY |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the instructions for use, operator's manual, and the patient guide for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and integration of instructions for use for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and focal segmental glomerulosclerosis. |
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