|
Device | MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P930029 |
Supplement Number | S021 |
Date Received | 12/10/2003 |
Decision Date | 02/05/2004 |
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 LINE EXTENSION TO THE COMMERCIALLY AVAILABLE RF ENHANCR CATHETER LINE WITH THE CHANGES LIMITED TO A NEW HANDLE DESIGN AND ASSOCIATED PACKAGING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC RF ENHANCR II FAMILY OF ABLATION CATHETERS AND IS INDICATED FOR USE WITH THE MEDTRONIC RF POWER GENERATOR TO DELIVER RF ENERGY FOR INTRACARDIAC ABLATION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA FOR THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA AND FOR CREATION OF COMPLETE AV BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA. |