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
Classification Namesystem, hemodynamic, implantable
Generic Namesystem, hemodynamic, implantable
Applicant
St. Jude Medical
387 technology circle nw
suite 500
atlanta, GA 30313
PMA NumberP100045
Supplement NumberS039
Date Received03/13/2019
Decision Date03/26/2019
Product Code
MOM[ Registered Establishments with MOM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change the air sampling method of the Controlled Access Environment located at the Atlanta facility.
-
-