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 GLUCOSE CONTROLLER |
| Generic Name | Controller, Closed-loop Blood Glucose |
| Applicant | MILES LABORATORIES, INC. |
| Date Received | 1983-04-28 |
| Decision Date | 1983-06-02 |
| PMA | P800032 |
| Supplement | S001 |
| Product Code | LHE |
| Advisory Committee | General Hospital |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MILES LABORATORIES, INC. 1127 Myrtle St. p.o. Box 40 elkhart, IN 46514 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800032 | Original Filing | |
| S001 | 1983-04-28 |