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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSPRINTER OVER THE WIRE (OTW) & SPRINTER MULTI-EXCHANGE (MX2) BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantMEDTRONIC IRELAND
PMA NumberP790017
Supplement NumberS088
Date Received07/30/2007
Decision Date08/29/2007
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
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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