| 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 | CONTAK CD (MODEL 1823), CONTAK CD 2 (MODELS H115 AND H119), RENEWAL (MODEL H135), RENEWAL 3 (MODELS H170, H175, H177, A |
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| Classification Name | defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) |
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| Generic Name | device resynchronization therapy-defibrillator (crt-d) system |
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| Applicant | GUIDANT CORP. |
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| PMA Number | P010012 |
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| Supplement Number | S026 |
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| Date Received | 03/29/2004 |
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| Decision Date | 09/14/2004 |
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| Product Code | |
| Docket Number | 04M-0430 |
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| Notice Date | 09/24/2004 |
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| Advisory Committee |
Cardiovascular |
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| Supplement Type | panel track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | Yes |
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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 contak cd, contak cd 2, renewal, and renewal 3 devices. These devices are indicated for patients with moderate to severe heart failure (nyha iii/iv) who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction (ef <= 35%) and qrs duration >= 120 ms. |
| Approval Order |
Approval Order
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