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.
 
DeviceCARDIOMEMS HF SYSTEM
Generic NameSystem, hemodynamic, implantable
ApplicantAbbott Medical
387 Technology Circle, NW
Suite 500
Atlanta, GA 30313
PMA NumberP100045
Supplement NumberS018
Date Received12/15/2016
Decision Date02/14/2017
Product Code MOM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the protocol, such as Quality of Life evaluations as well as minor clarifications for the post-approval study (PAS) protocol.
-
-