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U.S. Department of Health and Human Services

Premarket Approval - PMA

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Device Name
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PMA
Number
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Decision
Date
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vitagel rt3 delivery system STRYKER CORP. P050044S028 06/05/2014
livewire tc ablation catheter, safire ablation catheter St. Jude Medical P960016S050 07/09/2015
tacticath quartz set St. Jude Medical P130026S003 04/30/2015
livewire tc cardiac ablation system St. Jude Medical P960016S043 03/12/2014
elca coronary atherectomy catheters SPECTRANETICS CORP. P910001S051 02/17/2012
elca coronary atherectomy catheters SPECTRANETICS CORP. P910001S047 01/13/2012
sls spectranetics laser sheaths Spectranetics (Philips) P960042S032 02/17/2012
sls spectranetics laser sheaths Spectranetics (Philips) P960042S036 05/24/2012
osteo ceramic hip Smith & Nephew, Inc. P810048S007 03/22/1985
reflection ceramic hip system Smith & Nephew, Inc. P030022S025 08/30/2013

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