| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08) |
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| Generic Name | System, pacing, temporary, acute, internal atrial defibrillation |
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| Applicant | DOT MEDICAL PRODUCTS LTD.
3 BAILY COURT, GREEN STREET
MACCLESFIELD, CHESHIRE SK10 |
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| PMA Number | P990069 |
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| Date Received | 11/01/1999 |
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| Decision Date | 11/27/2002 |
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| Product Code |
MTE |
| Docket Number | 03M-0240 |
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| Notice Date | 06/24/2003 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | Yes |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08). THE ALERT SYSTEM IS INDICATED FOR USE IN PATIENTS WHO ARE CANDIDATES FOR TRANSVENOUS ELECTRICAL CARDIOVERSION FOR THE TREATMENT OF ATRIAL FIBRILLATION. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 |
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