| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | BIOSTATOR GCIIS |
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| Classification Name | controller, closed-loop blood glucose |
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| Generic Name | computerized infusion system |
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| Applicant | BAYER HEALTHCARE |
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| PMA Number | P790028 |
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| Date Received | 11/16/1979 |
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| Decision Date | 12/04/1980 |
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|
Withdrawal Date
|
10/05/2007 |
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| Product Code | |
| Notice Date | 02/20/1981 |
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| Advisory Committee |
General Hospital |
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| Expedited Review Granted? | No |
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| Combination Product |
No
|
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| Supplements: |
S001 S002 |
|
|
