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 | S109 |
Date Received | 02/08/2012 |
Decision Date | 03/09/2012 |
Product Code |
MDS |
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 IMPLEMENTATION OF A NEW CLEANING SYSTEM CALLED ISOPROPYL ALCOHOL RECIRCULATING CLEANING OR IPARC. THE IPARC SYSTEM IS USED TO CLEAN THE SENSOR BASE AND NEEDLE ASSEMBLY COMPONENTS OF THE SOF-SENSOR GLUCOSE SENSOR (MMT-7002, MMT-7003). THE SOF-SENSOR IS A COMPONENT OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME SYSTEM, CGMS IPRO SYSTEM AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM. |
|
|