| 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 | ROTABLATOR(R) |
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| Classification Name | catheter, peripheral, atherectomy |
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| Generic Name | rotational angioplasty system; atherectomy |
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| Regulation Number | 870.4875 |
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| Applicant | HEART TECHNOLOGY, INC. |
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| PMA Number | P900056 |
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| Supplement Number | S010 |
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| Date Received | 03/07/1995 |
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| Decision Date | 04/27/1995 |
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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 | labeling change - other |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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