|
Device | GIANTURCO-ROEHM 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 | S007 |
Date Received | 08/20/1999 |
Decision Date | 09/14/1999 |
Reclassified Date
|
05/01/2000 |
Product Code |
DTK |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to add a Patient Guide booklet to each device shipment. |