|
Device | RF ENHANCER 7 FRENCH, 5 MM ABLATION CATHETER |
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 | S017 |
Date Received | 03/18/2002 |
Decision Date | 05/31/2002 |
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 ABLATION CATHETERS WHICH FEATURE DESIGN CHANGES TO THE PERFORMER CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKED UNDER THE TRADE NAME RF ENHANCER 7FRENCH, 5 MM ABLATION CATHETER 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. |