|
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 | S041 |
Date Received | 02/12/2013 |
Decision Date | 04/16/2013 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MINOR MECHANICAL DESIGN MODIFICATIONS TO IMPROVE THE RUGGEDNESS OF THE LIFEVEST MODEL 4000 BATTERY CHARGER AND A MINOR MECHANICAL CHANGE TO THE MODEL 3000 BATTERY PACK. |