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 NumberS024
Date Received09/07/2010
Decision Date02/18/2011
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 Yes
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.
-
-