Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLIFEVEST WEARABLE DEFIBRILLATOR
Classification Namewearable automated external defibrillator
Generic Namewearable cardioverter defibrillator
ApplicantZOLL LIFECOR CORPRATION
PMA NumberP010030
Supplement NumberS037
Date Received10/19/2012
Decision Date12/20/2012
Product Code
MVK[ Registered Establishments with MVK ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a minor change in software/firmware for your lifevest wearable 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.
-
-