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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode LPC PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM SPECTRANETICS CORP. P910001 S108 11/16/2018
CVX-300 Excimer Laser System and ELCA Coronary Ath... SPECTRANETICS CORP. P910001 S107 10/15/2018
CVX-300 and CVX-300-P Excimer Laser Systems SPECTRANETICS CORP. P910001 S106 09/25/2018
ELCA Coronary Atherectomy Catheters SPECTRANETICS CORP. P910001 S105 08/14/2018
CVX-300 and CVX-300-P EXCIMER LASER SYSTEM SPECTRANETICS CORP. P910001 S089 07/27/2018
CVX-300-P Excimer Laser System SPECTRANETICS CORP. P910001 S097 06/29/2018
CVX-300 Excimer Laser System/ELCA Coronary Atherec... SPECTRANETICS CORP. P910001 S104 05/08/2018
ELCA Laser Catheters SPECTRANETICS CORP. P910001 S103 03/29/2018
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