Note: 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 | iPro2 CGM System |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150029 |
Supplement Number | S033 |
Date Received | 10/17/2019 |
Decision Date | 11/15/2019 |
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 Supplier of the Glucose Oxidase used in the fabrication of the Enlite Sensor and Guardian Sensor (3) moved their manufacturing facility from one location to another within the United Kingdom. |
|
|