P050019/s0179/27/13 carotid wallstent® monorail® endoprosthesis pgsooos chilli ii® cooled ablation catheter, model8005 circucool pump, model2104 tubingkit, sterile cables boston scientific corporation maple grove mn 55311 use of new traceability/tracking software in the incoming receiving inspection area.
| Device | WALLSTENT VENOUS ENDOPROSTHESIS |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | BOSTON SCIENTIFIC CORPORATION |
| Date Received | 2013-08-29 |
| Decision Date | 2013-09-27 |
| PMA | P980033 |
| Supplement | S036 |
| Product Code | MAF |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOSTON SCIENTIFIC CORPORATION one Scimed Place maple Grove, MN 55311-1566 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980033 | | Original Filing |
| S061 |
2022-11-14 |
30-day Notice |
| S060 |
2022-09-14 |
30-day Notice |
| S059 |
2022-06-03 |
30-day Notice |
| S058 |
2020-07-10 |
30-day Notice |
| S057 |
2020-06-16 |
30-day Notice |
| S056 |
2019-09-30 |
30-day Notice |
| S055 |
2019-06-27 |
30-day Notice |
| S054 |
2019-05-03 |
30-day Notice |
| S053 |
2019-03-22 |
30-day Notice |
| S052 |
2018-11-21 |
30-day Notice |
| S051 |
2018-11-21 |
30-day Notice |
| S050 | | |
| S049 |
2017-06-19 |
30-day Notice |
| S048 |
2017-06-01 |
30-day Notice |
| S047 |
2016-10-03 |
30-day Notice |
| S046 |
2016-09-13 |
30-day Notice |
| S045 |
2016-07-26 |
30-day Notice |
| S044 | | |
| S043 |
2015-03-09 |
Real-time Process |
| S042 | | |
| S041 |
2014-04-25 |
30-day Notice |
| S040 |
2013-11-26 |
30-day Notice |
| S039 |
2013-11-25 |
30-day Notice |
| S038 |
2013-11-04 |
30-day Notice |
| S037 |
2013-09-20 |
30-day Notice |
| S036 |
2013-08-29 |
30-day Notice |
| S035 |
2013-06-19 |
30-day Notice |
| S034 |
2013-06-10 |
30-day Notice |
| S033 |
2013-05-28 |
30-day Notice |
| S032 |
2013-05-09 |
30-day Notice |
| S031 |
2013-03-21 |
30-day Notice |
| S030 |
2013-01-15 |
30-day Notice |
| S029 |
2012-11-27 |
135 Review Track For 30-day Notice |
| S028 |
2012-11-19 |
30-day Notice |
| S027 |
2012-11-19 |
30-day Notice |
| S026 |
2012-10-15 |
30-day Notice |
| S025 |
2012-09-28 |
30-day Notice |
| S024 |
2012-09-05 |
30-day Notice |
| S023 |
2012-08-13 |
30-day Notice |
| S022 |
2012-06-15 |
30-day Notice |
| S021 |
2012-06-13 |
30-day Notice |
| S020 |
2012-04-18 |
30-day Notice |
| S019 |
2011-07-07 |
30-day Notice |
| S018 |
2011-02-10 |
135 Review Track For 30-day Notice |
| S017 |
2010-04-08 |
135 Review Track For 30-day Notice |
| S016 |
2010-01-26 |
30-day Notice |
| S015 |
2008-11-19 |
30-day Notice |
| S014 |
2006-05-09 |
30-day Notice |
| S013 |
2005-03-14 |
Normal 180 Day Track No User Fee |
| S012 |
2004-12-20 |
30-day Notice |
| S011 |
2004-06-25 |
30-day Notice |
| S010 |
2004-04-09 |
30-day Notice |
| S009 |
2003-12-08 |
30-day Notice |
| S008 |
2003-11-17 |
Normal 180 Day Track No User Fee |
| S007 |
2003-08-14 |
30-day Notice |
| S006 |
2003-03-12 |
Special (immediate Track) |
| S005 |
2002-12-18 |
30-day Notice |
| S004 |
2002-12-12 |
30-day Notice |
| S003 |
2002-05-29 |
30-day Notice |
| S002 |
2002-04-24 |
Normal 180 Day Track |
| S001 |
2001-12-20 |
Normal 180 Day Track |
NIH GUDID Devices