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U.S. Department of Health and Human Services

Premarket Approval - PMA
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PMA
Number
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Decision
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beta-cath xl delivery catheter - 60 mm BEST VASCULAR, INC P000018S021 10/25/2002
hancock ii porcine bioprosthesis model t505 (aortic) Medtronic, Inc. P980043S002 10/28/2002
nidek ec-5000 excimer laser system NIDEK CO., LTD. P970053S007 10/28/2002
staarvisc ii,shellgel and coease viscoelastics Anika Therapeutics, Inc. P000046S004 12/03/2002
s670 w/discrete technology(tm) otw/rapid exchange coronary stent system MEDTRONIC IRELAND P970035S039 04/17/2003
medtronic ave bridge extra support over-the-wire renal stent system Medtronic Vascular P020007S001 05/15/2003
st.jude medical riata defibrillation leads Abbott Medical P950022S017 07/01/2003
coseal surgical sealant BAXTER BIO SCIENCE P030039 12/12/2003
urolume endoprosthesis Boston Scientific Corp. P920023S018 10/15/2004
2490d/e carelink monitors Medtronic, Inc. P890003S078 10/25/2004

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