|
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 | S037 |
Date Received | 10/18/2012 |
Decision Date | 12/20/2012 |
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 A MINOR CHANGE IN SOFTWARE/FIRMWARE FOR YOUR LIFEVESTWEARABLE DEFIBRILLATOR (WCD 4000) DEVICE TO SUPPORT TWO FDA APPROVED ACCELEROMETERS. THE SOFTWARE/FIRMWARE CHANGE ENABLES THE SUBJECT DEVICE TO DETECT BETWEEN THE ACCELEROMETERS, TO CALIBRATE THE ACCELEROMETER AND ADJUST FOR ACCELEROMETER OUTPUT POLARITY. |