|
Device | THORATEC HEARTMATE II LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | Abbott Medical 6035 Stoneridge Drive Pleasanton, CA 94588 |
PMA Number | P060040 |
Supplement Number | S002 |
Date Received | 11/20/2008 |
Decision Date | 12/03/2008 |
Product Code |
DSQ |
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 THE ADDITION OF A CAUTION STATEMENT ''WARNING: PRECLOT THEGRAFT!" TO THE PACKAGE LABELS FOR THE OUTFLOW GRAFT WITH BEND RELIEF (CATALOG# 102563) ANDINFLOW CONDUIT (CATALOG # 102564). THIS CAUTION STATEMENT IS TO HIGHLIGHT INFORMATION CURRENTLYFOUND IN THE HEARTMATE II INSTRUCTIONS FOR USE, SECTION 13.4, WHICH INSTRUCTS USERS TO PRE-CLOT THE TWO COMPONENTS PRIOR TO IMPLANTATION. |