|
Device | STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEMS |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR DEVICES 3200 LAKESIDE DRIVE SANTA CLARA, CA 95054 |
PMA Number | P050007 |
Supplement Number | S010 |
Date Received | 07/02/2008 |
Decision Date | 07/23/2008 |
Product Code |
MGB |
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 FOR LABELING ADDITIONS TO THE INSTRUCTIONS FOR USE. |