|
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 | S042 |
Date Received | 02/12/2013 |
Decision Date | 07/22/2013 |
Product Code |
MVK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE WCD 4000 LIFEVEST® WEARABLE DEFIBRILLATOR AND THE SUBSEQUENT DISPLAY OF THAT INFORMATION ON THE SECURE LIFEVEST. |