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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
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP790017
Supplement NumberS086
Date Received12/04/2006
Decision Date08/17/2007
Reclassified Date 10/08/2010
Product Code LOX 
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
Approval Order Statement  
APPROVAL TO: 1) INTRODUCE AN AUTOMATED INFLATION DEVICE, REPLACING THE CURRENT MANUAL PROCESS, TO INFLATE PTCA BALLOONS PRIOR TO IN-PROCESS FUNCTIONAL TESTING; AND 2) REDUCE THE NUMBER OF SAMPLES WHICH ARE TAKEN TO MONITOR PARTICULATE LEVELS IN NITROGEN GAS AND COMPRESSED AIR.
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