|
Device | LIFEVEST WEARABLE DEFIBRILLATOR |
Generic Name | Wearable automated external defibrillator |
Applicant | ZOLL MANUFACTURING CORPORATION 121 GAMMA DR PITTSBURGH, PA 15238-0000 |
PMA Number | P010030 |
Supplement Number | S054 |
Date Received | 07/11/2014 |
Decision Date | 11/06/2015 |
Product Code |
MVK |
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 FOR AN ALTERNATE SUPPLIER OF AN OFF-THE-SHELF SDRAM INTEGRATED CIRCUIT (IC) USED ON THE LIFEVEST® WEARABLE DEFIBRILLATOR MODEL WCD 4000 COMPUTER PRINTED CIRCUIT BOARD ASSEMBLIES (PCA). THE ALTERNATE SUPPLIER IS INTEGRATED SILICON SOLUTIONS INC. (ISSI). THEDEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WEARABLE DEFIBRILLATOR 4000 AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. |