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 | GUARDIAN RT |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S012 |
Date Received | 02/28/2005 |
Decision Date | 08/24/2005 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE SENSOR TO INCLUDE THE USE OF HUMAN SERUM ALBUMIN IN PLACE OF BOVINE SERUM ALBUMIN AS A STABILIZER AND A CHANGE TO THE MANUFACTURING PROCESS REMOVING THE OUTER HYDROPHILIC MEMBRANE. |
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