Catheter, Electrode Recording, Or Probe, Electrode Recording
Basic Information
- Device Name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Trade Name
- CORDIS WEBSTER DIAGNOSITIC/ABLATION DEFLECTABLE TIP CATHETER & CATHETER-THERMOCOUPLE OR THERMISTOR
- PMA Number
- P950005
- Supplement Number
- S003
- Device Class
- FDA Class 2
- Product Code
- DRF
- Generic Name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 26, 1999
- Date Received
- July 27, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for expanded indications for use for the 6 Fr and 7 Fr Cordis Webster Diagnostic/Ablation Deflectable Tip Catheters and interface cables. In addition to the previously approved indications for interruption of accessory AV conduction pathways associated with tachycardia, the treatment of AV nodal reentrant tachycardia (AVNRT), and creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia, your ablation system is now approved to treat patients with the following Indications for Use: 1) Pediatric Patients (age 4 years or older); 2) Patients with Persistent Junctional Reciprocating Tachycardia (PJRT); and 3) Patients with Mahaim Fibers.
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 |
|---|---|---|---|
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | FDA class 2 | Cardiovascular |