|
Device | MINILINK REAL TIME TRANSMITTER |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150019 |
Supplement Number | S025 |
Date Received | 11/28/2016 |
Decision Date | 12/19/2016 |
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 Add a new mold and press during the supplier’s manufacture of the Glucose Sensing Transmitter/Recorder bottom cover component of various Medtronic glucose monitoring systems. |