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. |
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Device | IBI THERAPY CARDIAC ABLATION SYSTEM |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | IRVINE BIOMEDICAL, INC. 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P040014 |
Supplement Number | S006 |
Date Received | 02/12/2007 |
Decision Date | 03/16/2007 |
Product Code |
LPB |
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 A NEW RF GENERATOR, WHICH INCLUDES SOFTWARE AND HARDWARE MODIFICATIONS TO THE PREVIOUSLY APPROVED RF GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERAPY ABLATION CATHETER AND IBI 1500T9 RT ABLATION GENERATOR. THE THERAPY ABLATION CATHETER IS INDICATED FOR MAPPING AND FOR USE WITH THE IBI 1500T9 RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETE AV NODAL BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA. THE IBI 1500T9 RF ABLATION GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ST. JUDE MEDICAL TEMPERATURE CONTROLLED ABLATION CATHETERS FOR CREATING ENDOCARDIAL LESIONS TO TREAT CARDIAC ARRHYTHMIAS (I.E. SUPRAVENTRICULAR TACHYCARDIAS, AND ATRIAL FLUTTER). THE GENERATOR IS INTERNALLY LIMITED TO 50 WATTS WHEN USED WITH THE THERAPY ABLATION CATHETERS. |
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