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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 NameAMER, ED. LABS. PTCA
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca coronary angioplasty catheter
Regulation Number870.5100
ApplicantABBOTT VASCULAR INC.
PMA NumberP850021
Date Received04/03/1985
Decision Date05/30/1986
Withdrawal Date 06/30/2009
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 86M-0259
Notice Date 07/09/1986
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 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 
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