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 | MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S083 |
Date Received | 08/20/2010 |
Decision Date | 10/06/2010 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MINOR MODIFICATION TO THE DESIGN OF THE PARADIGM REAL-TIME PUMP CASE (MODELS MMT-522, MMT-522K, MMT-523, MMT-523K) TO ALLOW FOR A ¿TWO SHOT¿ MOLDING TECHNOLOGY FOR THE MANUFACTURE OF THE MAIN CASE BY A NEW SUPPLIER. |
|
|