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 | ATAKR(R) RFCA ABLATION SYSTEM |
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 | S014 |
Date Received | 06/28/2000 |
Decision Date | 07/31/2000 |
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 MODIFICATION TO THE TIP ELECTRODE LENGTH (5 MM). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONDUCTR(R) MC-5MM, AND IS INDICATED FOR THE INTERRUPTION 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. |
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