| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | NAVISTAR & EZ STEER FAMILIES OF CATHETERS |
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| Classification Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
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| Generic Name | radiofrequency ablation catheter; electrode recording catheter |
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| Applicant | BIOSENSE WEBSTER, INC. |
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| PMA Number | P010068 |
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| Supplement Number | S011 |
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| Date Received | 10/05/2007 |
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| Decision Date | 10/29/2007 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | 30-day notice |
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| Supplement Reason | process change: sterilization |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Change to the ethylene oxide sterilization cycle process parameters. |
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