| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). |
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| Generic Name | Lipoprotein, low density, removal |
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| Applicant | Kaneka Pharma America Corp.
546 Fifth Ave., 21st Floor
New York, NY 10036 |
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| PMA Number | P910018 |
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| Date Received | 03/26/1991 |
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| Decision Date | 02/21/1996 |
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| Product Code |
MMY |
| Docket Number | 96M-0193 |
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| Notice Date | 07/01/1996 |
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| Advisory Committee |
Gastroenterology/Urology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE LIPOSORBER LA-15 SYSTEM. THE DEVICE IS A LOW DENSITY LIPOPROTEIN (LDL) APHERESIS SYTEM |
| Supplements: |
S001 S002 S005 S006 S007 S009 S011 S012 S013 S015 S016
S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028
S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040
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