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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.
 
DeviceMEDTRONIC(R) CORONARY BALLOON DILATATION CATHETERS MODELS 18K, 14K SPIRT, EVERGREEN, FALCON AND PANTHER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMEDTRONICS INTERVENTIONAL VASCULAR
3576 UNO CAL PLACE
SANTA ROSA, CA 95403
PMA NumberP870036
Supplement NumberS035
Date Received04/07/1995
Decision Date04/27/1995
Withdrawal Date 06/09/2008
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type 30-Day Supplement
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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