|
Device | MINIMED 530G INSULIN PUMPS |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S065 |
Date Received | 03/18/2015 |
Decision Date | 04/16/2015 |
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 TRANSFER OF PURCHASING, RECEIVING, AND INCOMING INSPECTION ACTIVITIES OFCERTAIN EXTERNAL INSULIN PUMP COMPONENTS USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIMEPUMP SERIES AND THE MINIMED 530G SERIES FROM THE MEDTRONIC MINIMED NORTHRIDGE FACILITY TO THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY AND FEDEX/3PL FACILITIES IN PUERTO RICO. THE PARADIGM REAL쳌]TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED 530G SYSTEM, RESPECTIVELY. |