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 | PROSORBA COLUMN |
Generic Name | Separator, automated, blood cell and plasma, therapeutic |
Applicant | FRESENIUS HEMOCARE, INC. 920 WINTER STREET WALTHAM, MA 02451 |
PMA Number | P850020 |
Supplement Number | S015 |
Date Received | 04/15/2002 |
Decision Date | 05/15/2002 |
Withdrawal Date
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04/14/2008 |
Product Code |
LKN |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement REDUCTION IN THE TIME OF THE REACTION STEP IN THE MANUFACTURING PROCESS AND A DECREASE IN THE AMOUNT OF CARBODIIMIDE USED IN THE PROCESS. |
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