| 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 | PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIO OPEN CELL (OC) STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYSTEM |
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| Classification Name | stent, coronary |
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| Generic Name | intravascular coronary stent |
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| Applicant | ABBOTT VASCULAR DEVICES |
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| PMA Number | P000011 |
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| Supplement Number | S009 |
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| Date Received | 07/02/2003 |
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| Decision Date | 12/08/2003 |
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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 - specifications |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for the addition of an 8 mm stent in diameters of 3. 0, 3. 5, and 4. 0 mm for the biodivysio oc otw system. |
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