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 SYSTEM |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S080 |
Date Received | 11/27/2015 |
Decision Date | 12/23/2015 |
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 TWO SUB-ASSEMBLY PROCESSES FOR THE PARADIGMREAL쳌 TIME, PARADIGM REAL쳌 TIME REVEL, AND MINIMED 530G INSULIN PUMPS FROM MEDTRONIC MINIMED IN NORTHRIDGE, CA TO MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM REAL ]TIME AND REAL쳌 TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGMREAL쳌]TIME AND REAL쳌 TIME REVEL SYSTEMS, RESPECTIVELY. THE MINIMED 530G INSULIN PUMP IS A COMPONENT OF THE MINIMED 530G SYSTEM. |
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