| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | MINIMED 530G INSULIN PUMP |
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| Generic Name | Automated insulin dosing , threshold suspend |
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| Applicant | Medtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325 |
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| PMA Number | P120010 |
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| Supplement Number | S033 |
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| Date Received | 08/11/2014 |
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| Decision Date | 10/08/2014 |
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| Product Code |
OZO |
| Advisory Committee |
Clinical Chemistry |
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| Clinical Trials | NCT01112696
|
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| Supplement Type | 135 Review Track For 30-Day Notice |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR A CHANGE TO A SUPPLIER¿S PRODUCTION LINE FOR A MOTOR PART OF THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-523K,MMT-723 AND MMT-723K) AND THE MINIMED 530G INSULIN PUMPS (MODELS MMT-551 AND MMT-751). THE INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM, PARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE MINIMED 530G SYSTEM RESPECTIVELY. |
| Post-Approval Study | Show Report Schedule and Study Progress |
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