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 | SOF SENSOR |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S158 |
Date Received | 06/23/2014 |
Decision Date | 07/24/2014 |
Product Codes |
MDS OYC |
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 CHANGE IN THE CONCENTRATION OF A RAW MATERIAL USED DURING MANUFACTURE OF THE ENLITETM GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM AND SOFTM GLUCOSE SENSOR (MMT-7002, MMT-7003) OF THE PARADIGM® REAL-TIME SYSTEM AND PARADIGM® REAL-TIME REVEL SYSTEM. |
|
|