System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
Basic Information
- Device Name
- System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
- Trade Name
- RESPONSE CV CATHETER SYSTEM
- PMA Number
- P020052
- Device Class
- FDA Class 3
- Product Code
- MTE
- Generic Name
- System, pacing, temporary, acute, internal atrial defibrillation
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- May 7, 2003
- Date Received
- December 2, 2002
- Expedited Review
- N
- Docket Number
- 03M-0343
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MTE | System, Pacing, Temporary, Acute, Internal Atrial Defibrillation | FDA class 3 | Unknown |