| 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 | ULTRA2 CUTTING BALLOON MONORAIL(MR) |
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| Classification Name | catheter, angioplasty, peripheral, transluminal |
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| Generic Name | catheter, transluminal coronary angioplasty, percutaneous |
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| Regulation Number | 870.1250 |
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| Applicant | BOSTON SCIENTIFIC CORPORATION |
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| PMA Number | P950020 |
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| Supplement Number | S012 |
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| Date Received | 11/08/2004 |
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| Decision Date | 03/16/2005 |
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| Product Code | |
| Advisory Committee |
Cardiovascular |
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| Supplement Type | normal 180 day track no user fee |
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| Supplement Reason | location change: manufacturer |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for manufacturing sites located at interventional technologies europe, ltd. , donegal, ireland and ebis iotron, ltd. , oxon, great britain. |
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