|
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 | S049 |
Date Received | 03/25/2014 |
Decision Date | 05/19/2014 |
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 29 ROHS COMPLIANT ALTERNATE COMPONENTS, 7 ROHS COMPLIANT ALTERNATE BARE-BOARD SUBASSEMBLIES, AND 6 ROHS COMPLIANT ALTERNATE CABLE SUBASSEMBLIES FOR USE IN THE LIFEVEST WEARABLE DEFIBRILLATOR. |