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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode NVY PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
 
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DURATA, DURATA, OPTISURE Abbott Medical P950022 S089 04/28/2016
OPTISURE FAMILY OF HIGH VOLTAGE LEADS Abbott Medical P950022 S090 01/08/2016
DURATA AND OPTISURE HV LEADS Abbott Medical P950022 S091 02/17/2016
TENDRIL SDX LEAD, TENDRIL ST LEAD, OPTISENSE, TEND... Abbott Medical P960013 S078 04/28/2016
TENDRIL SDX, ST, STS, AND OPTISCIENSE L V LEADS Abbott Medical P960013 S079 02/17/2016
PROTEGO SD 60/16,PROTEGO SD 65/16,PROTEGO SD 75/18... BIOTRONIK, INC. P980023 S066 01/28/2016
SELECTSECURE LEAD MEDTRONIC CARDIAC RHYTHM DISEA P030036 S081 01/13/2016
SELECTSECURE LEAD MEDTRONIC CARDIAC RHYTHM DISEA P030036 S082 03/03/2016
SELECTSECURE LEAD MEDTRONIC CARDIAC RHYTHM DISEA P030036 S083 01/25/2016
SELECTSECURE LEAD MEDTRONIC CARDIAC RHYTHM DISEA P030036 S084 01/21/2016
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