|
Device | THORATEC HEARTMATE XVE AND VE LEFT VENTRICULAR ASSIST SYSTEM (LVAS) |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC CORP. 6035 STONERIDGE DR. PLEASANTON, CA 94588 |
PMA Number | P920014 |
Supplement Number | S023 |
Date Received | 01/09/2004 |
Decision Date | 07/08/2004 |
Withdrawal Date
|
10/03/2014 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR USE OF THE POWERSONIC SEALED LEAD ACID BATTERY (MODEL PS-1223) AS A REPLACEMENT FOR THE NO LONGER MANUFACTURED PANASONIC SEALED LEAD ACID BATTERY (MODEL LC-SA122R3EU) AS A SOURCE OF BATTERY POWER TO DRIVE THE HEARTMATE VE AND ZVE LEFT VENTRICULAR ASSIST SYSTEMS. |