|
Device | PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
PMA Number | P960043 |
Supplement Number | S080 |
Date Received | 07/20/2012 |
Decision Date | 04/15/2013 |
Product Code |
MGB |
Docket Number | 13M-0464 |
Notice Date | 05/07/2013 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE PERCLOSE® PROGLIDE¿ SUTURE MEDIATED CLOSURE SYSTEM. THIS DEVICE IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTSWHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CATHETERIZATION PROCEDURES USING 5F TO 21 F SHEATHS; FOR SHEATH SIZES GREATER THAN 8F, AT LEAST TWO DEVICES AND THE PRE-CLOSE TECHNIQUE AREREQUIRED. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|