|
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 | S004 |
Date Received | 11/08/2013 |
Decision Date | 11/23/2015 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES IN THE WELDING PROCESS OF THE CLEAR PLASTIC WINDOW TO THE PUMP CASE OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K), THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K) AND THE MINIMED 530G INSULIN PUMP (MODEL: MMT-551). THE PARADIGM REAL-TIME INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME SYSTEM; THE PARADIGM REAL-TIME REVEL INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME REVEL SYSTEM; AND THE MINIMED 530G INSULIN PUMP IS A PART OF THE MINIMED 530G SYSTEM. |