VERIFLEX FOR LIBERTE BARE METAL STENTS

FDA Premarket Approval P040016 S037

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval to add an alternate trade name for the libertÉ monorail and over-the-wire coronary stent systems. The device will be marketed under the trade name veriflex bare metal coronary stent and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease with stenotic lesions in native coronary arteries (length

DeviceVERIFLEX FOR LIBERTE BARE METAL STENTS
Generic NameStent, Coronary
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
Date Received2009-09-15
Decision Date2009-09-25
PMAP040016
SupplementS037
Product CodeMAF 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC SCIMED, INC. one Scimed Place maple Grove, MN 55311

Supplemental Filings

Supplement NumberDateSupplement Type
P040016Original Filing
S134 2014-11-14 135 Review Track For 30-day Notice
S133
S132 2014-09-19 30-day Notice
S131 2014-06-13 Normal 180 Day Track No User Fee
S130
S129 2014-04-28 135 Review Track For 30-day Notice
S128 2014-04-07 30-day Notice
S127 2014-03-31 30-day Notice
S126 2014-03-28 30-day Notice
S125 2014-02-25 30-day Notice
S124 2014-02-24 30-day Notice
S123 2014-02-21 30-day Notice
S122 2014-01-15 30-day Notice
S121 2014-01-14 30-day Notice
S120 2013-12-30 30-day Notice
S119 2013-11-26 30-day Notice
S118 2013-11-25 30-day Notice
S117 2013-09-20 30-day Notice
S116 2013-09-19 30-day Notice
S115 2013-08-29 30-day Notice
S114 2013-06-10 30-day Notice
S113 2013-03-25 135 Review Track For 30-day Notice
S112
S111
S110 2013-03-29 Normal 180 Day Track
S109
S108 2013-01-28 30-day Notice
S107 2013-01-16 30-day Notice
S106 2012-11-27 30-day Notice
S105 2012-11-19 30-day Notice
S104 2012-11-16 30-day Notice
S103 2012-11-16 30-day Notice
S102 2012-11-13 30-day Notice
S101 2012-11-02 30-day Notice
S100 2012-10-31 30-day Notice
S099 2012-10-15 30-day Notice
S098 2012-10-11 30-day Notice
S097 2012-09-05 30-day Notice
S096 2012-09-04 30-day Notice
S095 2012-08-13 30-day Notice
S094 2012-08-03 30-day Notice
S093 2012-07-13 135 Review Track For 30-day Notice
S092 2012-07-02 30-day Notice
S091 2012-06-27 135 Review Track For 30-day Notice
S090 2012-06-27 30-day Notice
S089 2012-06-14 30-day Notice
S088 2012-05-02 30-day Notice
S087 2012-04-27 30-day Notice
S086 2012-04-18 30-day Notice
S085 2012-03-23 30-day Notice
S084 2012-02-03 30-day Notice
S083 2011-12-13 135 Review Track For 30-day Notice
S082 2011-11-07 30-day Notice
S081 2011-10-24 30-day Notice
S080 2011-10-14 30-day Notice
S079 2011-09-30 30-day Notice
S078 2011-09-15 30-day Notice
S077
S076 2011-08-31 30-day Notice
S075 2011-07-05 30-day Notice
S074 2011-06-27 30-day Notice
S073 2011-06-21 Normal 180 Day Track No User Fee
S072 2011-06-01 30-day Notice
S071 2011-04-01 30-day Notice
S070 2011-02-22 30-day Notice
S069 2010-12-22 135 Review Track For 30-day Notice
S068 2010-12-22 30-day Notice
S067 2010-12-20 30-day Notice
S066 2010-12-17 30-day Notice
S065 2010-12-14 30-day Notice
S064 2010-10-21 30-day Notice
S063 2010-10-08 135 Review Track For 30-day Notice
S062 2010-08-02 30-day Notice
S061 2010-07-14 30-day Notice
S060 2010-06-09 30-day Notice
S059 2010-06-07 135 Review Track For 30-day Notice
S058 2010-05-24 30-day Notice
S057 2010-04-16 30-day Notice
S056 2010-04-15 30-day Notice
S055 2010-04-08 135 Review Track For 30-day Notice
S054 2010-03-08 Real-time Process
S053 2010-02-01 30-day Notice
S052 2010-01-26 30-day Notice
S051 2010-01-26 30-day Notice
S050 2010-01-25 30-day Notice
S049 2010-01-19 30-day Notice
S048 2009-12-31 30-day Notice
S047 2009-12-24 135 Review Track For 30-day Notice
S046 2009-12-03 30-day Notice
S045 2009-12-03 30-day Notice
S044 2009-11-10 30-day Notice
S043 2009-11-09 30-day Notice
S042 2009-11-06 30-day Notice
S041 2009-11-06 30-day Notice
S040 2009-11-05 30-day Notice
S039 2009-11-05 30-day Notice
S038 2009-10-30 30-day Notice
S037 2009-09-15 Special (immediate Track)
S036 2009-08-31 30-day Notice
S035 2009-03-30 30-day Notice
S034 2008-10-30 Real-time Process
S033 2008-08-28 30-day Notice
S032 2008-07-02 30-day Notice
S031 2008-05-19 30-day Notice
S030 2008-04-21 30-day Notice
S029 2008-03-31 30-day Notice
S028 2008-01-28 30-day Notice
S027 2007-12-19 30-day Notice
S026 2007-08-23 135 Review Track For 30-day Notice
S025
S024 2007-05-11 30-day Notice
S023 2007-03-16 30-day Notice
S022 2007-02-13 Real-time Process
S021 2006-12-21 135 Review Track For 30-day Notice
S020 2006-12-07 135 Review Track For 30-day Notice
S019 2006-11-30 135 Review Track For 30-day Notice
S018 2006-09-21 135 Review Track For 30-day Notice
S017 2006-09-07 30-day Notice
S016 2006-09-01 135 Review Track For 30-day Notice
S015 2006-08-31 30-day Notice
S014 2006-08-24 30-day Notice
S013 2006-08-24 30-day Notice
S012 2006-06-20 135 Review Track For 30-day Notice
S011 2006-05-23 30-day Notice
S010 2006-05-09 30-day Notice
S009 2006-04-13 30-day Notice
S008 2006-02-06 30-day Notice
S007 2005-11-21 30-day Notice
S006 2005-10-03 30-day Notice
S005 2005-09-22 Normal 180 Day Track No User Fee
S004 2005-09-15 Normal 180 Day Track No User Fee
S003
S002
S001 2005-05-10 30-day Notice

NIH GUDID Devices

Device IDPMASupp
08714729395454 P040016 000
08714729395799 P040016 000
08714729395782 P040016 000
08714729395775 P040016 000
08714729395768 P040016 000
08714729395751 P040016 000
08714729395744 P040016 000
08714729395737 P040016 000
08714729395720 P040016 000
08714729395805 P040016 000
08714729395812 P040016 000
08714729395911 P040016 000
08714729395904 P040016 000
08714729395898 P040016 000
08714729395867 P040016 000
08714729395850 P040016 000
08714729395843 P040016 000
08714729395836 P040016 000
08714729395829 P040016 000
08714729395713 P040016 000
08714729395706 P040016 000
08714729395553 P040016 000
08714729395546 P040016 000
08714729395539 P040016 000
08714729395508 P040016 000
08714729395492 P040016 000
08714729395485 P040016 000
08714729395478 P040016 000
08714729395461 P040016 000
08714729395560 P040016 000
08714729395577 P040016 000
08714729395690 P040016 000
08714729395669 P040016 000
08714729395652 P040016 000
08714729395645 P040016 000
08714729395638 P040016 000
08714729395621 P040016 000
08714729395614 P040016 000
08714729395584 P040016 000
08714729395928 P040016 000
08714729395959 P040016 000
08714729396291 P040016 000
08714729396284 P040016 000
08714729396277 P040016 000
08714729396260 P040016 000
08714729396253 P040016 000
08714729396246 P040016 000
08714729396239 P040016 000
08714729396222 P040016 000
08714729396307 P040016 000
08714729396314 P040016 000
08714729471400 P040016 000
08714729471394 P040016 000
08714729471387 P040016 000
08714729396383 P040016 000
08714729396376 P040016 000
08714729396369 P040016 000
08714729396352 P040016 000
08714729396321 P040016 000
08714729396215 P040016 000
08714729396208 P040016 000
08714729396055 P040016 000
08714729396048 P040016 000
08714729396031 P040016 000
08714729396000 P040016 000
08714729395997 P040016 000
08714729395980 P040016 000
08714729395973 P040016 000
08714729395966 P040016 000
08714729396062 P040016 000
08714729396079 P040016 000
08714729396192 P040016 000
08714729396161 P040016 000
08714729396154 P040016 000
08714729396147 P040016 000
08714729396130 P040016 000
08714729396123 P040016 000
08714729396116 P040016 000
08714729396086 P040016 000
08714729471417 P040016 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.