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: S002
• Date Received: 04/09/1991
• Decision Date: 05/02/1991
• Reclassified Date: 05/01/2000
• Product Code: DTK
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No