| 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 | PRIZM |
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| Generic Name | cardiac resynchronization therapy defibrillator (crt-d) system |
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| Applicant | GUIDANT CORP. |
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| PMA Number | P960040 |
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| Supplement Number | S076 |
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| Date Received | 08/15/2005 |
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| Decision Date | 09/13/2005 |
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| Advisory Committee |
Cardiovascular |
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| Supplement Type | 30-day notice |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Addition of an inline temperature and humidity controlled cure tunnel to fill channels. |
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