| 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 RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM |
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| Generic Name | Cardiac ablation percutaneous catheter |
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| Applicant | Medtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112 |
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| PMA Number | P930029 |
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| Supplement Number | S010 |
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| Date Received | 11/04/1997 |
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| Decision Date | 12/18/1997 |
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| Product Code |
LPB |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order 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 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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