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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSPECTRANETICS CVX-300 EXCIMER LASER CORONARY ANGIOPLASTY (ELCA) SYSTEM
Generic NameDEVICE, ANGIOPLASTY, LASER, CORONARY
ApplicantSpectranetics Corp.
9965 Federal Dr.
Colorado Springs, CO 80921
PMA NumberP910001
Supplement NumberS027
Date Received10/30/2008
Decision Date03/25/2009
Product Code LPC 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) REMOVAL OF BIOBURDEN TESTING FROM THE LOT HISTORY RECORDS (LHR) AS A TEST REQUIRED FOR RELEASE OF PRODUCT, AND 2) CHANGE LAL ENDOTOXIN TEST PROCEDURE TO INSTRUCT QUALITY ASSOCIATES TO COLLECT PRODUCT SAMPLE POST-STERILIZATION.
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