Premarket Approval (PMA)

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.

• Device: COOK BIRD'S NEST 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: S001
• Date Received: 03/21/1991
• Decision Date: 12/08/1992
• Reclassified Date: 05/01/2000
• Product Code: DTK
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No