|
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 | S009 |
Date Received | 01/28/2014 |
Decision Date | 02/27/2014 |
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 IN THE INSULIN PUMP CASE ASSEMBLY MANUFACTURING PROCESS AT MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC) TO RECEIVE PUMP CASES DIRECTLY FROM A SUPPLIER WITH A NEW KEYPAD AND OVERLAY. THE INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM. |