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.
| Device | BIOSTATOR GCIIS |
| Generic Name | Controller, Closed-loop Blood Glucose |
| Applicant | BAYER HEALTHCARE |
| Date Received | 1983-04-21 |
| Decision Date | 1983-08-08 |
| PMA | P790028 |
| Supplement | S002 |
| 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 |