| 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 | CVX-300 LASER SYSTEM |
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| Classification Name | device, angioplasty, laser, coronary |
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| Generic Name | coronary angioplasty catheter |
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| Applicant | SPECTRANETICS CORP. |
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| PMA Number | P910001 |
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| Supplement Number | S033 |
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| Date Received | 09/14/2009 |
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| Decision Date | 07/08/2010 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | normal 180 day 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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Approval Order Statement
Approval for changes to the cvx-300 excimer laser system for compliance to electrical safety and electromagnetic compatibility voluntary standards. |
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