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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAMER, ED. LABS. PTCA
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD
TEMECULA, CA 92591
PMA NumberP850021
Date Received04/03/1985
Decision Date05/30/1986
Withdrawal Date 06/30/2009
Product Code LOX 
Docket Number 86M-0259
Notice Date 07/09/1986
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028  S029 S030 S031 
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