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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.
 
DeviceELCA CORONARY ATHERECTOMY CATHETERS
Generic NameDEVICE, ANGIOPLASTY, LASER, CORONARY
ApplicantSPECTRANETICS CORP.
9965 Federal Drive
Colorado Springs, CO 80921
PMA NumberP910001
Supplement NumberS060
Date Received07/02/2012
Decision Date07/31/2012
Product Code LPC 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGES TO THE ON-DEMAND LABEL PRINTING SYSTEM.
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