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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.
 
DeviceMAXXUM PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
SCIMED LIFE SYSTEMS, INC.
one scimed place
maple grove, MN 55311-1566
PMA NumberP860019
Supplement NumberS156
Date Received08/03/1999
Decision Date02/01/2000
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional approval for the maxxum ptca catheter (balloon diamters ranging from 2. 5-4. 0 mm), the post-delivery expansion of balloon expandable stents.
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