Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | BIOSTATOR GCIIS |
Generic Name | Controller, closed-loop blood glucose |
Applicant | BAYER HEALTHCARE 430 South Beiger Street MISHAWAKA, IN 46544 |
PMA Number | P790028 |
Supplement Number | S001 |
Date Received | 10/04/1982 |
Decision Date | 11/18/1982 |
Withdrawal Date
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10/05/2007 |
Product Code |
LHE |
Advisory Committee |
General Hospital |
Expedited Review Granted? | No |
Combination Product | No |
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