|
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 | S023 |
Date Received | 08/17/2010 |
Decision Date | 04/19/2011 |
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 |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR UPDATED BARE BOARD ARTWORK FOR USE IN THE LIFEVEST WEARABLE DEFIBRILLATOR WCD 4000. |
Approval Order | Approval Order |