|
Device | Medtronic MiniMed iPro2 CGM System with Elite Sensor |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150029 |
Supplement Number | S018 |
Date Received | 03/26/2018 |
Decision Date | 05/23/2018 |
Product Codes |
MDS OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of contamination controls at a supplier during manufacturing of liquid glucose oxidase. The glucose oxidase is used in production of Enlite and Guardian glucose sensors. |