Biostator Glucose Controller
by Miles Laboratories, Inc. PMA
Active
PMA P800032
Overview
The Biostator Glucose Controller is a closed-loop blood glucose controller device designed to regulate blood glucose levels. It operates as a medical device that continuously monitors and adjusts glucose levels in the bloodstream.
This device is supplied by Miles Laboratories, Inc. and is authorized under FDA PMA number P800032. It is a Class III medical device with the product code LHE, manufactured in Elkhart, Indiana.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP800032 | Date28 May 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Generic Name
- Controller, closed-loop blood glucose
- PMA Number
- FDA Product Code
- LHE
- Device Class
- Class III
- Advisory Committee
- General Hospital
- FDA Decision
- APPR Approved
Other devices from Miles Laboratories, Inc.
Questions
What is the Biostator Glucose Controller used for?
The Biostator Glucose Controller is a closed-loop blood glucose controller device designed to continuously monitor and adjust glucose levels in the bloodstream to help regulate blood glucose levels.
How is the Biostator Glucose Controller supplied?
The device is supplied by Miles Laboratories, Inc., and is manufactured in Elkhart, Indiana at 1127 Myrtle St., P.O. Box 40.
What is the regulatory status of the Biostator Glucose Controller?
The device is authorized under FDA PMA number P800032 and is classified as a Class III medical device with the product code LHE.
Is the Biostator Glucose Controller a single-use or reusable device?
The device data does not specify whether the Biostator Glucose Controller is single-use or reusable, so this information is not available.