| 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 | SJM EPIC VALVE AND SJM EPIC SUPRA VALVE |
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| Classification Name | replacement heart-valve |
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| Generic Name | replacement heart valve |
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| Regulation Number | 870.3925 |
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| Applicant | ST. JUDE MEDICAL, INC. |
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| PMA Number | P040021 |
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| Supplement Number | S004 |
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| Date Received | 09/29/2006 |
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| Decision Date | 11/15/2007 |
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| Product Code | |
| Docket Number | 08M-0084 |
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| Notice Date | 02/05/2008 |
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| Advisory Committee |
Cardiovascular |
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| Supplement Type | panel track |
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| Supplement Reason | change design/components/specifications - other |
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| Expedited Review Granted? | No |
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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 epic valve in aortic sizes 21, 23, 25, 27 and 29 mm, and in mitral sizes 27, 29, 31 and 33 mm, and the sjm epic supra valve in aortic valve sizes 19, 21, 23, 25 and 27 mm. The device is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve. |
| Approval Order |
Approval Order
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