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 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.
 
DeviceRESPONSE CV CATHETER SYSTEM
Generic NameSystem, pacing, temporary, acute, internal atrial defibrillation
ApplicantSt. Jude Medical
14901 DEVEAU PLACE
MINNEAPOLIS, MN 55345-2126
PMA NumberP020052
Date Received12/02/2002
Decision Date05/07/2003
Withdrawal Date 04/17/2015
Product Code MTE 
Docket Number 03M-0343
Notice Date 08/26/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE RESPONSE CV CATHETER SYSTEM, WHICH INCLUDES THE FOLLOWING COMPONENTS: SJM CARDIOVERSION RESPONSE (CV) ELECTROPHYSIOLOGY CATHETER; SJM CV ELECTROPHYSIOLOGY EXTENSION CABLE; SJM CARDIOVERSION SWITCHBOX SYSTEM; AND SJM CARDIOVERSION CABLE. THIS SYSTEM IS INDICATED AS FOLLOWS: THE SJM CARDIOVERSION RESPONSE (CV) ELECTROPHYSIOLOGY CATHETER WHEN USED WITH THE SJM CV ELECTROPHYSIOLOGY EXTENSION CABLE AND SJM SWITCHBOX SYSTEM IS INDICATED FOR USE IN THE INVASIVE EVALUATION OF CARDIAC ARRHYTHMIAS AND CAN BE USED FOR INTRACARDIAC CARDIOVERSION OF ATRIAL TACHYARRHYTHMIAS. THE SJM CV ELECTROPHYSIOLOGY EXTENSION CABLE IS INTENDED TO CONNECT A SJM RESPONSE (CV) CARDIOVERSION ELECTROPHYSIOLOGY CATHETER TO A SJM CARDIOVERSION SWITCHBOX SYSTEM. THE SJM CARDIOVERSION SWITCHBOX SYSTEM IS INTENDED TO CONNECT A SJM CARDIOVERSION (CV) ELECTROPHYSIOLOGY CATHETER AND SJM CV ELECTROPHYSIOLOGY EXTENSION CABLE TO A COMPATIBLE CARDIOVERTER/ DEFIBRILLATOR AND EP RECORDING SYSTEM. THE SJM CARDIOVERSION CABLE IS INTENDED TO CONNECT THE SJM CARDIOVERSION SWITCHBOX SYSTEM TO A COMPATIBLE CARDIOVERTER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 
-
-