| 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 | 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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| Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
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| Applicant | Boston Scientific Corp
4100 Hamline Ave. N
St Paul, MN 55112 |
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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 |
NIK |
| 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/instructions/shelf life/tradename |
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| Expedited Review Granted? | Yes |
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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 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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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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