|
Device | MMT-7002 & MMT-7003 GLUCOSE SENSORS |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S060 |
Date Received | 09/28/2009 |
Decision Date | 10/28/2009 |
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 REPLACING THE PUDDLE CASTING PROCESS WITH A SLOT COATING PROCESS AND IMPLEMENTATION OF A HEAT TREATMENT PROCESS FOR THE O-RINGS. |