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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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itrel(r) 3 system MEDTRONIC NEUROMODULATION P840001S050 07/26/2001
novoste beta-cath system BEST VASCULAR, INC P000018S008 10/26/2001
novoste beta-cath system BEST VASCULAR, INC P000018S009 10/26/2001
angiojet rheolytic xmi thrombectomy catheter Boston Scientific Corp. P980037S004 11/20/2001
closer / closer s 6 french smc systems ABBOTT VASCULAR INC. P960043S031 11/20/2001
soft-55 ew aphakic (vifilcon a) soft(hydrophilic) spherical contact lens for extended wear UNILENS CORPORATION USA P960039S002 01/03/2002
medtronic synchromed infusion system MEDTRONIC Inc. P860004S051 05/14/2002
contak cd system Boston Scientific Corp. P010012S001 05/20/2002
ats open pivot bileaflet MEDTRONIC ATS MEDICAL, INC. P990046S006 05/29/2002
bte (behind-the-ear) system sensor (adult) ADVANCED BIONICS CORP. P940022S021 06/06/2002

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