ATAKR(R) RFCA ABLATION SYSTEM
FDA premarket approval P930029/S014 · decided 2000-07-31
Approval details
- PMA number
- P930029
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATAKR(R) RFCA ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Medtronic, Inc.
- Date received
- 2000-06-28
- Decision date
- 2000-07-31
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- 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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