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Device | RESPONSE CV CATHETER SYSTEM |
Generic Name | System, pacing, temporary, acute, internal atrial defibrillation |
Applicant | St. Jude Medical 14901 DEVEAU PLACE MINNEAPOLIS, MN 55345-2126 |
PMA Number | P020052 |
Date Received | 12/02/2002 |
Decision Date | 05/07/2003 |
Withdrawal Date
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04/17/2015 |
Product Code |
MTE |
Docket Number | 03M-0343 |
Notice Date | 08/26/2003 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S003 S004 S005 S006 S007 S008 S009 |