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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 49 Results
productcode MDS PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Device
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PMA
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dexcom g5 mobile continuous glucose monitoring sys... DEXCOM, INC. P120005 S080 03/15/2019
dexcom g5 mobile continuous glucose monitoring sys... DEXCOM, INC. P120005 S081 04/24/2019
dexcom g4 platinum continuous glucose monitoring s... DEXCOM, INC. P120005 S082 08/20/2019
t:slim x2 insulin pump with dexcom g5 mobile cgm s... Tandem Diabetes Care, Inc. P140015 S028 03/01/2019
t:slim x2 insulin pump with dexcom g5 mobile cgm s... Tandem Diabetes Care, Inc. P140015 S029 12/19/2019
real-time revel system MEDTRONIC MINIMED P150019 S053 03/13/2019
paradigm real-time rvel system MEDTRONIC MINIMED P150019 S054 03/11/2019
paradigm real-time revel system MEDTRONIC MINIMED P150019 S056 07/18/2019
paradigm real-time revel system MEDTRONIC MINIMED P150019 S057 08/14/2019
paradigm real-time revel system MEDTRONIC MINIMED P150019 S058 08/26/2019
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