| 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 | ON-X PROSTHETIC HEART VALVE |
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| Classification Name | heart-valve, mechanical |
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| Generic Name | replacement heart valve |
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| Applicant | ON-X TECHNOLOGIES, INC |
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| PMA Number | P000037 |
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| Supplement Number | S017 |
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| Date Received | 11/17/2009 |
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| Decision Date | 01/14/2010 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | real-time process |
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| Supplement Reason | change design/components/specifications - material |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval to change the material specifications for the sewing cuff ptfe fabric used in the assembly of the on-x valve. |
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