|
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 | S006 |
Date Received | 10/07/1998 |
Decision Date | 12/21/1998 |
Reclassified Date
|
05/01/2000 |
Product Code |
DTK |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for a change to the packaging. |