|
Device | ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | ABIOMED CARDIOVASCULAR, INC. 22 CHERRY HILL DRIVE DANVERS, MA 01923 |
PMA Number | P900023 |
Supplement Number | S039 |
Date Received | 12/15/2003 |
Decision Date | 12/23/2003 |
Withdrawal Date
|
02/01/2018 |
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 AN ADDITIONAL LABEL IN THE FORM OF A PACKAGING STICKER STATING, "ONLY USE THREADED RESTRAINTS WITH THE AB5000 VENTRICLE. USE OF NON-THREADED CANNULA RESTRAINTS MAY RESULT IN: 1) CANNULAE BECOMING DISCONNECTED FROM THE VENTRICLE, AND 2) THROMBUS FORMATION." |