| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER WITH 5MM TIP ELECTRODE |
|---|
| Generic Name | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING |
|---|
| Regulation Number | 870.1220 |
|---|
| Applicant | Biosense Webster, Inc
31 Technology Drive
Suite 200
Irvine, CA 92618 |
|---|
| PMA Number | P950005 |
|---|
| Supplement Number | S004 |
|---|
| Date Received | 02/22/1999 |
|---|
| Decision Date | 04/05/1999 |
|---|
| Product Code |
DRF |
| Advisory Committee |
Cardiovascular |
|---|
| Supplement Type | Real-Time Process |
|---|
| Supplement Reason | Change Design/Components/Specifications/Material |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
Approval for the 7 Fr and 8 Fr catheters incorporating a 5mm tip electrode. The device, as modified, will be marketed under the trade name Celsius(TM) Diagnostic/Ablation Deflectable Braided Tip Catheter (5mm Tip Electrode) and is indicated for interruption of accessory AV conduction pathways assocated 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. In addition to these indications, the 7 Fr catheter is also indicated for persistent junctional reciprocating tachycardia, Mahaim fibers, and pediatric patients (age 4 years or older). |
|
|
