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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
ApplicantMEDTRONICS INTERVENTIONAL VASCULAR
PMA NumberP870036
Date Received06/16/1987
Decision Date03/25/1988
Withdrawal Date 06/09/2008
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 88M-0160
Notice Date 06/24/1988
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 
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