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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHeartStart OnSite and Home Defibrillator
Generic NameOver-the-counter automated external defibrillator
ApplicantPHILIPS MEDICAL SYSTEMS, INC.
22100 BOTHELL -EVERETT HWY
BOTHELL, WA 98021
PMA NumberP160029
Supplement NumberS008
Date Received01/07/2021
Decision Date04/06/2021
Product Codes MKJ NSA 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a change in speaker component for the HeartStart FRx, OnSite, and Home Defibrillator devices.
-
-