|
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 | S062 |
Date Received | 06/04/2015 |
Decision Date | 06/30/2015 |
Product Code |
MVK |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MAKE THE ¿MONITOR DETECT AND TREAT¿ TEST PERMANENT; AUTOMATE THE MONITOR DETECT AND TREAT TEST; REPLACE THE EXISTING AUTOTEST MONITOR PULSE TEST WITH THE AUTOMATED MONITOR DETECT AND TREAT TEST IN A SUBSEQUENT STEP OF THE PRODUCTION PROCESS. |