|
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 | S024 |
Date Received | 09/07/2010 |
Decision Date | 02/18/2011 |
Product Code |
MVK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR SOFTWARE CHANGES INCLUDING ASYSTOLE NOTIFICATION HANDLING, LOW BATTERY NOTIFICATION HANDLING, AND POWER UP RESPONSE BUTTON SEQUENCE IN ADDITION TO LABELING UPDATES RESULTING FROM THOSE CHANGES. |