510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PZEClass III

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

Unknown
FDA source (opens on fda.gov)

PZE is the FDA product code for Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated, a class III device type. FDA's definition for this code reads: "A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration...". As of , FDA records hold no 510(k) clearances under this code and 3 recalls.

Classification record

Product code
PZE
Device name
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA definition
A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and also provides historical glucose information, facilitating long-term therapy adjustments.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
3

Companies listing this code with FDA

Companies whose registered establishments list this code