|
Device | MINIMED 530G INSULIN PUMP |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S059 |
Date Received | 01/28/2015 |
Decision Date | 02/25/2015 |
Product Code |
OZO |
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 TO AUTOMATE A PROCESS TO PRESS THE GEARBOX SHAFTS INTO THE SUN AND PLANETARY WHEELS OF THE 530G INSULIN PUMP DRIVE MOTOR. THE 530G INSULIN PUMP IS A COMPONENT OF THE MINIMED 530G SYSTEM. |