Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER
• Classification Name: filter, intravascular, cardiovascular
• Generic Name: vena cava filter
• Regulation Number: 870.3375
• Applicant: COOK, INC.
• PMA Number: P850049
• Supplement Number: S007
• Date Received: 08/20/1999
• Decision Date: 09/14/1999
• Product Code: DTK [ Registered Establishments with DTK ]
• Advisory Committee: Cardiovascular
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval to add a patient guide booklet to each device shipment.