| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF |
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| Classification Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
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| Applicant | IRVINE BIOMEDICAL, INC. |
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| PMA Number | P060019 |
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| Date Received | 05/30/2006 |
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| Decision Date | 03/16/2007 |
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| Product Code | |
| Docket Number | 07M-0108 |
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| Notice Date | 03/26/2007 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the therapy cool path ablation catheter and ibi 1500t9 rf ablation generator. The therapy cool path ablation catheter is intended for use with a compatible external infusion pump and the ibi 1500t9 radiofrequency (rf) generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter. The ibi 1500t9 rf ablation generator is intended for use with compatible st. Jude medical temperature controlled ablation catheters for creating endocardial lesions to treat cardiac arrhythmias (i. E. Supraventricular tachycardias, and atrial flutter). The generator is internally limited to 50 watts when used with the therapy cool path catheters. A compatible external infusion pump must be connected when used with therapy cool path catheters. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S002 S003 S004 S005 S007
S008 S009 S010 S011 S013 S014
S015 S016 S017 S019 S020 S021
S022 S023 |
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