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 Home Defibrillator and HeartStart Onsite Defibrillator
Generic NameOver-the-counter automated external defibrillator
ApplicantPHILIPS MEDICAL SYSTEMS, INC.
22100 BOTHELL -EVERETT HWY
BOTHELL, WA 98021
PMA NumberP160029
Supplement NumberS011
Date Received03/22/2021
Decision Date04/19/2021
Product Codes MKJ NSA 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Change to the audio production test manufacturing specification performed during the Final Acceptance Test.
-
-