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.
Approval for changes to the protocol for the post-approval study (pas) protocol.
| Device | XIENCE V NANO, XIENCE PRIME XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; HI-TORQUE PROGRESS, PILOT GUIDE |
| Classification Name | Coronary Drug-eluting Stent |
| Generic Name | Coronary Drug-eluting Stent |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2016-07-08 |
| Decision Date | 2017-03-03 |
| PMA | P070015 |
| Supplement | S133 |
| Product Code | NIQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | ABBOTT VASCULAR INC. 26531 Ynez Road, Building G p.o.box 9018 temecula, CA 92589-9018 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070015 | Original Filing | |
| S148 | 2021-02-22 | 30-day Notice |
| S147 | 2020-02-13 | 30-day Notice |
| S146 | 2019-09-26 | 135 Review Track For 30-day Notice |
| S145 | 2019-06-12 | 30-day Notice |
| S144 | 2019-01-24 | 30-day Notice |
| S143 | 2018-09-05 | 30-day Notice |
| S142 | 2018-03-23 | 30-day Notice |
| S141 | 2018-03-01 | Normal 180 Day Track |
| S140 | 2018-01-26 | 30-day Notice |
| S139 | 2017-12-11 | Normal 180 Day Track No User Fee |
| S138 | 2017-09-28 | 135 Review Track For 30-day Notice |
| S137 | 2017-05-17 | 30-day Notice |
| S136 | 2017-04-05 | 30-day Notice |
| S135 | 2016-11-23 | 30-day Notice |
| S134 | 2016-09-12 | 135 Review Track For 30-day Notice |
| S133 | 2016-07-08 | Normal 180 Day Track No User Fee |
| S132 | 2015-11-16 | 135 Review Track For 30-day Notice |
| S131 | 2015-09-25 | 30-day Notice |
| S130 | ||
| S129 | ||
| S128 | 2015-02-02 | Panel Track |
| S127 | 2015-01-14 | 30-day Notice |
| S126 | 2014-09-26 | 30-day Notice |
| S125 | 2014-09-25 | 30-day Notice |
| S124 | 2014-08-27 | 30-day Notice |
| S123 | 2014-04-14 | 30-day Notice |
| S122 | 2014-03-21 | Panel Track |
| S121 | 2014-03-18 | 30-day Notice |
| S120 | 2014-02-10 | 30-day Notice |
| S119 | 2013-12-23 | 135 Review Track For 30-day Notice |
| S118 | 2013-12-12 | 30-day Notice |
| S117 | 2013-11-27 | Normal 180 Day Track No User Fee |
| S116 | 2013-10-24 | 30-day Notice |
| S115 | 2013-10-18 | 30-day Notice |
| S114 | 2013-09-30 | 30-day Notice |
| S113 | 2013-07-29 | 30-day Notice |
| S112 | 2013-05-31 | 30-day Notice |
| S111 | 2013-05-17 | 135 Review Track For 30-day Notice |
| S110 | 2013-05-14 | 30-day Notice |
| S109 | 2013-04-30 | Normal 180 Day Track No User Fee |
| S108 | 2013-04-08 | Normal 180 Day Track No User Fee |
| S107 | 2013-04-02 | Normal 180 Day Track |
| S106 | 2013-01-22 | 30-day Notice |
| S105 | ||
| S104 | 2012-11-09 | 30-day Notice |
| S103 | ||
| S102 | 2012-10-02 | 30-day Notice |
| S101 | 2012-09-28 | 30-day Notice |
| S100 | ||
| S099 | 2012-08-13 | 30-day Notice |
| S098 | 2012-07-30 | 30-day Notice |
| S097 | 2012-07-20 | 30-day Notice |
| S096 | 2012-06-11 | 30-day Notice |
| S095 | ||
| S094 | 2012-06-19 | Normal 180 Day Track |
| S093 | 2012-05-14 | 135 Review Track For 30-day Notice |
| S092 | 2012-03-12 | Normal 180 Day Track No User Fee |
| S091 | 2012-02-23 | 30-day Notice |
| S090 | 2012-02-06 | 30-day Notice |
| S089 | 2012-02-03 | 30-day Notice |
| S088 | 2012-02-01 | 135 Review Track For 30-day Notice |
| S087 | 2012-01-24 | Normal 180 Day Track No User Fee |
| S086 | 2012-01-09 | 135 Review Track For 30-day Notice |
| S085 | 2011-12-21 | 30-day Notice |
| S084 | ||
| S083 | 2011-10-24 | 30-day Notice |
| S082 | 2011-10-19 | Normal 180 Day Track |
| S081 | 2011-10-11 | 30-day Notice |
| S080 | 2011-08-30 | 30-day Notice |
| S079 | 2011-08-02 | 30-day Notice |
| S078 | 2011-07-26 | 30-day Notice |
| S077 | 2011-07-22 | Normal 180 Day Track |
| S076 | 2011-07-18 | 30-day Notice |
| S075 | 2011-06-09 | 135 Review Track For 30-day Notice |
| S074 | 2011-06-01 | 30-day Notice |
| S073 | ||
| S072 | 2011-05-09 | 135 Review Track For 30-day Notice |
| S071 | 2011-05-02 | 135 Review Track For 30-day Notice |
| S070 | 2011-04-18 | Normal 180 Day Track No User Fee |
| S069 | 2011-04-13 | 30-day Notice |
| S068 | 2011-04-11 | 30-day Notice |
| S067 | 2011-04-04 | 30-day Notice |
| S066 | 2011-03-30 | 30-day Notice |
| S065 | 2011-03-29 | 30-day Notice |
| S064 | 2011-03-28 | 135 Review Track For 30-day Notice |
| S063 | 2011-03-28 | 30-day Notice |
| S062 | 2011-03-21 | 30-day Notice |
| S061 | 2011-03-18 | 30-day Notice |
| S060 | 2011-02-11 | 135 Review Track For 30-day Notice |
| S059 | 2011-03-04 | 30-day Notice |
| S058 | 2011-02-11 | 135 Review Track For 30-day Notice |
| S057 | ||
| S056 | 2011-02-01 | 30-day Notice |
| S055 | 2010-12-02 | 30-day Notice |
| S054 | 2010-11-26 | Panel Track |
| S053 | 2010-11-15 | 30-day Notice |
| S052 | 2010-11-01 | 30-day Notice |
| S051 | 2010-10-13 | 30-day Notice |
| S050 | 2010-10-12 | 30-day Notice |
| S049 | ||
| S048 | 2010-09-14 | 30-day Notice |
| S047 | 2010-09-07 | 30-day Notice |
| S046 | 2010-09-03 | 135 Review Track For 30-day Notice |
| S045 | 2010-09-02 | 135 Review Track For 30-day Notice |
| S044 | 2010-08-05 | 30-day Notice |
| S043 | 2010-07-27 | 30-day Notice |
| S042 | 2010-07-23 | 30-day Notice |
| S041 | 2010-07-22 | 30-day Notice |
| S040 | 2010-06-23 | 30-day Notice |
| S039 | 2010-06-22 | 30-day Notice |
| S038 | 2010-06-18 | 135 Review Track For 30-day Notice |
| S037 | 2010-05-13 | 30-day Notice |
| S036 | 2010-04-29 | Normal 180 Day Track |
| S035 | 2010-04-23 | 30-day Notice |
| S034 | 2010-04-20 | 30-day Notice |
| S033 | 2010-03-23 | 30-day Notice |
| S032 | 2010-02-01 | 30-day Notice |
| S031 | 2010-01-19 | 135 Review Track For 30-day Notice |
| S030 | ||
| S029 | 2009-11-24 | 30-day Notice |
| S028 | 2009-11-12 | Real-time Process |
| S027 | 2009-10-21 | 30-day Notice |
| S026 | 2009-09-22 | 30-day Notice |
| S025 | 2009-09-21 | 30-day Notice |
| S024 | 2009-09-15 | 30-day Notice |
| S023 | 2009-07-29 | 30-day Notice |
| S022 | 2009-07-21 | 135 Review Track For 30-day Notice |
| S021 | 2009-06-24 | 30-day Notice |
| S020 | 2009-06-03 | 30-day Notice |
| S019 | 2009-06-02 | 30-day Notice |
| S018 | 2009-05-19 | 30-day Notice |
| S017 | 2009-05-01 | 135 Review Track For 30-day Notice |
| S016 | 2009-04-30 | 30-day Notice |
| S015 | 2009-04-13 | 30-day Notice |
| S014 | 2009-03-02 | 135 Review Track For 30-day Notice |
| S013 | 2009-02-26 | 30-day Notice |
| S012 | 2009-02-02 | 30-day Notice |
| S011 | 2009-01-21 | 30-day Notice |
| S010 | 2009-01-14 | Real-time Process |
| S009 | ||
| S008 | 2008-11-17 | 30-day Notice |
| S007 | 2008-11-05 | 30-day Notice |
| S006 | 2008-09-15 | 30-day Notice |
| S005 | 2008-08-21 | 30-day Notice |
| S004 | 2008-08-08 | 30-day Notice |
| S003 | 2008-07-29 | 30-day Notice |
| S002 | 2008-07-18 | Normal 180 Day Track |
| S001 | 2008-07-16 | Normal 180 Day Track |