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.
 
DeviceMFC-CPRD Cable Assembly used with X Series and R Series Device
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantZOLL MEDICAL CORPORATION
269 & 271 MILL ROAD
CHELMSFORD, MA 01824-4105
PMA NumberP160022
Supplement NumberS003
Date Received04/30/2018
Decision Date05/18/2018
Product Code MKJ 
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 the manufacturing site location of its cable accessories manufacturing operations for the R Series and X Series device to another existing facility.
-
-