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U.S. Department of Health and Human Services

Premarket Approval - PMA
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Device Name
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PMA
Number
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Decision
Date
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viscoat(tm) ALCON LABORATORIES P840064S008 08/29/1990
lithostar SIEMENS CORP. P870018S005 02/05/1992
model pc-10 post chamber iol ADVANCED MEDICAL OPTICS, INC. P820049S055 11/09/1992
hemashield woven double velour grafts 7mmx100cm MAQUET CARDIOVASCULAR, LLC P840029S008 05/11/1993
usci(r) silk(tm)/agil(tm) ball.dil.cath. w/pro/pel MEDTRONIC IRELAND P790017S044 01/07/1994
kelvin(r) model 513 unipolar and model 514 bipolar cardiac pulse generators. COOK PACEMAKER CORP. P870054S014 07/12/1995
oxycell BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC N5798S007 07/24/1995
schneider freehand(r) ptca catheters BOSTON SCIENTIFIC P880027S037 07/31/1995
model 4553 dual cham. ddd temp.cardiac pacemaker PACE MEDICAL P920032S001 08/28/1995
aosept (r) lens cup & aodisc neutralizer CIBA VISION CARE P820040S032 10/23/1995

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