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 | ENLITE SENSOR |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S030 |
Date Received | 07/07/2014 |
Decision Date | 02/04/2015 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE SENSOR BASE WHICH INCLUDED; THE ADDITION OF ANTI-ROTATION PINS AND SNAP ARMS, MODIFICATION OF THE O-RING GLAND; WIDTH, POSITION, AND DIAMETER, AN INCREASE TO THE BORE SIZE AND ADDITION OF A BORE TAPER, A SENSOR THROUGH-HOLE SIZE INCREASE, AND CONNECTOR PAD SURFACE HEIGHT INCREASE, ON THE ENLITETM GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM. |
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