ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM
FDA premarket approval P930029/S010 · decided 1997-12-18
Approval details
- PMA number
- P930029
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Medtronic, Inc.
- Date received
- 1997-11-04
- Decision date
- 1997-12-18
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval to implement design changes in the RF Performr catheter that will result in the ability of the catheter to deflect in two directions rather than one and the inclusion of a self reference electrode on some models. The device, as modified, will be marketed under the trade name the RF Conductr MC Self-Reference Catheters and is indicated for the interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia, for the treatment of AV nodal re-entrant tachycar
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