Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | HEARTMATE XVE LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC CORP. 6035 STONERIDGE DR. PLEASANTON, CA 94588 |
PMA Number | P920014 |
Supplement Number | S015 |
Date Received | 02/23/2001 |
Decision Date | 05/31/2001 |
Withdrawal Date
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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 |
Approval Order Statement APPROVAL TO INCLUDE THE HEARTMATE. XVE LVAS UNDER P920014, WITH THE SAME INDICATIONS FOR USE AS FOR THE PREVIOUSLY APPROVED (IN SUPPLEMENT S7, APPROVAL LETTER DATED OCTOBER 6, 1998) VE LVAS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEARTMATE. XVE LVAS AND IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES AT RISK OF IMMINENT DEATH FROM NONREVERSIBLE LEFT VENTRICULAR FAILURE. THE HEARTMATE. SVE LVAS IS INDICATED FOR USE BOTH INSIDE AND OUTSIDE THE HOSPITAL. |
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