This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | BIOSTATOR GCIIS |
| Generic Name | Controller, Closed-loop Blood Glucose |
| Applicant | BAYER HEALTHCARE |
| Date Received | 1979-11-16 |
| Decision Date | 1980-12-04 |
| Notice Date | 1981-02-20 |
| PMA | P790028 |
| Supplement | S |
| Product Code | LHE |
| Advisory Committee | General Hospital |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BAYER HEALTHCARE 430 South Beiger Street mishawaka, IN 46544 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790028 | Original Filing | |
| S002 | 1983-04-21 | |
| S001 | 1982-10-04 |