| 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 | DURATA, RIATA, RIATA ST, AND RIATA ST OPTIM FAMILY OF LEADS |
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| Classification Name | implantable cardioverter defibrillator (non-crt) |
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| Generic Name | transvenous defibrillation lead |
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| Applicant | ST. JUDE MEDICAL, INC. |
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| PMA Number | P950022 |
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| Supplement Number | S063 |
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| Date Received | 08/04/2009 |
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| Decision Date | 09/29/2009 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | real-time process |
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| Supplement Reason | process change: manufacturing |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for design and process modifications of the dr-1 connector pin on the durata, riata, riata st and riata st optim families of leads. |
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