|
Device | LIFEVEST WAERABLE DEFIBRILLATOR |
Generic Name | Wearable automated external defibrillator |
Applicant | ZOLL MANUFACTURING CORPORATION 121 GAMMA DR PITTSBURGH, PA 15238-0000 |
PMA Number | P010030 |
Supplement Number | S031 |
Date Received | 10/20/2011 |
Decision Date | 11/02/2012 |
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 SEVERAL HARDWARE DESIGN CHANGES AND A SOFTWARE DRIVER UPATE. |
Approval Order | Approval Order |