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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.
 
DeviceOVER THE WIRE DILATATION CATHETERS
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMEDTRONIC IRELAND
Parkmore Business Park West
Galway 
PMA NumberP790017
Supplement NumberS068
Date Received12/10/1998
Decision Date01/08/1999
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  
The 30-Day Notice requested to modify the sterilization parameters to address the excessively long Ethylene Oxide residue quarantine times by reducing as exposure minor modifications to the sterilization parameters are also being introduced to improve efficiency and increase flexibility at the contract sterilization facility.
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