| 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 | CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROTHESIS, MODELS 2700, 2700TFX, 2800,2800TFX, 3000, 3000TFX,6900P (PERI... |
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| Classification Name | replacement heart-valve |
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| Generic Name | bioprosthetic heart valve |
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| Regulation Number | 870.3925 |
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| Applicant | EDWARDS LIFESCIENCES, LLC. |
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| PMA Number | P860057 |
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| Supplement Number | S024 |
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| Date Received | 09/27/2004 |
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| Decision Date | 12/29/2004 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | 135 review track for 30-day notice |
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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 an alternative liquid sterilant processing solution. |
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