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 | PARADIGM REAL-TIME INSULIN PUMP |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S114 |
Date Received | 03/05/2012 |
Decision Date | 04/04/2012 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement USE OF AN ALTERNATIVE SUPERCAPACITOR DUE TO A SUPPLY CHAIN PROBLEM. THESUPERCAPACITOR 1037110-003 (NEC P/N: FGH0H154ZF-H5E) WILL REPLACE 1037110-002 (NECPIN: FGH0H154ZF-LE) FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS MMT-522, -522K,-722, -722K) AND PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT -523, -523K, -723,-723K). THE PARADIGM REAL-TIME PUMP IS A COMPONENT OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM. THE PARADIGM REAL-TIME REVEL PUMP IS A COMPONENT OF THEPARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM. |
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