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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 NameVERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantVERSAFLEX DELIVERY SYSTEMS, INC.
PMA NumberP870036
Supplement NumberS003
Date Received02/21/1989
Decision Date06/06/1989
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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