PMA P120010S040

Device: ENLITE SENSOR
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S040
Product code: OZO
Decision date: 2015-05-13
Classification: Automated Insulin Dosing , Threshold Suspend
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: APPROVAL FOR A CHANGE IN THE CALCULATION METHOD USED TO DETERMINE THE AMOUNT OF PLATINUM TO ADD IN THE MANUFACTURE OF THE PLATINUM SOLUTION USED IN THE FABRICATION PROCESS FOR THE SOF-SENSOR AND ENLITE SENSORS, AND FOR THE ENLITE SENSOR ONLY, THE ADDITION OF EQUIPMENT USED TO VERIFY THE PLATINUM SOLUTION CONCENTRATION.

Current openFDA PMA Record#

Device: ENLITE SENSOR
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S040
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2015-05-13
Decision code: APPR
Date received: 2014-10-30
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE CALCULATION METHOD USED TO DETERMINE THE AMOUNT OF PLATINUM TO ADD IN THE MANUFACTURE OF THE PLATINUM SOLUTION USED IN THE FABRICATION PROCESS FOR THE SOF-SENSOR AND ENLITE SENSORS, AND FOR THE ENLITE SENSOR ONLY, THE ADDITION OF EQUIPMENT USED TO VERIFY THE PLATINUM SOLUTION CONCENTRATION.