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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.
 
DeviceSPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP790017
Supplement NumberS088
Date Received07/30/2007
Decision Date08/29/2007
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDING ISOTRON IRELAND, ONE OF MEDTRONIC?S APPROVED CONTRACT ETHYLENE OXIDE (ETO) STERILIZATION FACILITIES, TO RECEIVE, STORE, AND PREPARE BIOLOGICAL INDICATORS FOR ROUTINE STERILIZATION CYCLES AND TO COMPLETE VIABILITY TESTING.
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