• 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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTACTICATH QUARTZ SET
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Generic Namecatheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Applicant
St. Jude Medical
one st. jude medical drive
st. paul, MN 55117
PMA NumberP130026
Date Received11/29/2013
Decision Date10/24/2014
Product Code
OAE[ Registered Establishments with OAE ]
Docket Number 14M-1736
Notice Date 11/21/2014
Advisory Committee Cardiovascular
Clinical Trials NCT01278953
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR THE TACTICATH QUARTZ CATHETER AND TACTISYSQUARTZ® EQUIPMENT. THIS DEVICE IS INDICATED FOR USE IN CARDIACELECTROPHYSIOLOGICAL MAPPING AND FOR THE TREATMENT OF DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED IN CONJUNCTION WITH A COMPATIBLE RADIOFREQUENCY GENERATOR AND THREE-DIMENSIONAL MAPPING SYSTEM.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S026 S027 
-
-