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 | LIFEVEST (WCD 3100) DEVICE |
Generic Name | Wearable automated external defibrillator |
Applicant | ZOLL MANUFACTURING CORPORATION 121 GAMMA DR PITTSBURGH, PA 15238-0000 |
PMA Number | P010030 |
Supplement Number | S007 |
Date Received | 03/06/2006 |
Decision Date | 11/01/2006 |
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 HARDWARE CHANGE TO INTEGRATE THE PENDANT ALARM MODULE INTO THE MONITOR ENCLOSURE, HARDWARE CHANGE TO THE COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY TO IMPROVE EMI IMMUNITY AND REPLACE SEVERAL OBSOLETE COMPONENTS, SOFTWARE CHANGES TO INTERACT WITH THE REVISED COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY, LABELING CHANGES TO ACCOMMODATE THE INTEGRATED ALARM MODULE, AND TO IMPROVE READABILITY, LABELING CHANGES TO PROVIDE A SPANISH VERSION OF THE PATIENT MANUAL, PATIENT CHECKLIST, AND CORRESPONDING AUDIO/DISPLAY MESSAGES FOR SPANISH SPEAKING PATIENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WCD 3100 AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. |
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