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 | ARTIFICIAL PANCREAS DEVICE SYSTEM |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S045 |
Date Received | 11/04/2014 |
Decision Date | 12/04/2014 |
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 IMPLEMENTATION OF FIVE ADDITIONAL PIECES OF EQUIPMENT AT A CONTRACT MANUFACTURER TO SUPPORT THE MANUFACTURE OF THE LITHIUM POLYMER BATTERIES FOR THE MINILINKREAL-TIME TRANSMITTER MODEL NUMBER MMT-7703 AND THE IPRO2 DIGITAL RECORDER MODEL NUMBER MMT-7741. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL쳌] TIME SYSTEM, PARADIGM REAL쳌] TIME REVEL SYSTEM, GUARDIAN REAL쳌]TIME SYSTEM, MINILINKREAL쳌]TIME SYSTEM, AS WELL AS THE MINIMED 530G SYSTEM. THE IPRO2 RECORDER IS A COMPONENT OF THE IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM. |
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