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 | GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER |
Generic Name | FILTER, INTRAVASCULAR, CARDIOVASCULAR |
Regulation Number | 870.3375 |
Applicant | COOK, INC. P.O. BOX 489 BLOOMINGTON, IN 47402 |
PMA Number | P850049 |
Supplement Number | S008 |
Date Received | 06/13/2000 |
Decision Date | 02/13/2002 |
Reclassified Date
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05/01/2000 |
Product Code |
DTK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT COOK INC., BLOOMINGTON, INDIANA. |
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