|
Device | LIFEVEST WEARABLE BEFIBRILLATOR |
Generic Name | Wearable automated external defibrillator |
Applicant | ZOLL MANUFACTURING CORPORATION 121 GAMMA DR PITTSBURGH, PA 15238-0000 |
PMA Number | P010030 |
Supplement Number | S028 |
Date Received | 05/10/2011 |
Decision Date | 07/07/2011 |
Product Code |
MVK |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR USE OF THE E-ONE MOLI ENERGY 1HR18650B (2.25AH) LITHIUM-ION BATTERY CELL WITH YOUR LIFEVEST MODEL 4000 WEARABLE DEFIBRILLATOR. |