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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.
 
DeviceGRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER (NC STORMER OTW & NC STORMER MX2)
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP790017
Supplement NumberS092
Date Received08/01/2007
Decision Date08/30/2007
Reclassified Date 10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
REDUCTION IN THE NUMBER OF SAMPLES SUBMITTED FOR IN-PROCESS QUALITY CONTROL TENSILE TESTING OF THE DEVICE.
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