• 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.
 
DeviceAnthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF
Generic Namepulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
ApplicantAbbott Medical
15900 valley view court
sylmar, CA 91335
PMA NumberP030035
Supplement NumberS166
Date Received01/31/2018
Decision Date02/22/2018
Product Code NKE 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Adjust the relative humidity in the device and leads manufacturing and product packaging areas located in the Sylmar, California facility.
-
-