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.
 
DeviceTatiCath Quartz Set
Generic NameCatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
ApplicantSt. Jude Medical
One St. Jude Medical Drive
St. Paul, MN 55117
PMA NumberP130026
Supplement NumberS032
Date Received02/21/2018
Decision Date05/16/2018
Product Code OAE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for elimination of a field service procedure for the TactiSys Quartz equipment, and minor IFU revisions to reflect the removal of the service procedure.
-
-