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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 NameAMER, ED. LABS. PTCA
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nametransluminal coronary angioplasty catheters, percu
Regulation Number870.5100
ApplicantAMERICAN EDWARDS LABORATORIES
PMA NumberP850021
Supplement NumberS004
Date Received10/09/1987
Decision Date06/06/1988
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
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