Approval for the spectranetics cvx-300(tm) excimer laser system, including the models pc1014 and pc1017 laser catheters. This system is indicated for use in patients with single or multivessel coronary artery disease either as a stand alone modality or in conjunction with percutaneous transluminal coronary balloon angioplasty (ptca) and who are acceptable candidates for coronary artery bypass graft (cabg) surgery. Adjunctive balloon angioplasty was performed, at the clinical investigator's discretion, in 84 percent of the lesions treated. Clinical experience has provided reasonable assurance that the spectraneticics cvx-300(tm) excimer laser system and multifiber laser catheters are safe and effective for the following indications:occluded saphenous vein bypass grafts; ostial lesions; long lesions (greater than 20 mm in length); moderately calcified stenoses (heavily calcified stenoses are those lesions that demonstrate complete calcification when identified under fluoroscopy prior to the procedure. Moderately and slightly calcified stenoses are all others. ); total occlusions traversable by a guidewire; and lesions which have previously failed balloon angioplasty (this includes those lesions that were treated unsuccessfully by ptca. Lesions that have undergone a complicated ptca procedure are not included in this category. ) these lesions must be traversable by a guidewire and composed of athersclerotic plaque and/or calcified material. The lesions should be well defined by angiography.
| Device | SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM |
| Classification Name | Device, Angioplasty, Laser, Coronary |
| Generic Name | Device, Angioplasty, Laser, Coronary |
| Applicant | SPECTRANETICS CORP. |
| Date Received | 1991-02-08 |
| Decision Date | 1993-02-19 |
| Notice Date | 1993-03-24 |
| PMA | P910001 |
| Supplement | S |
| Product Code | LPC |
| Docket Number | 93M-0086 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SPECTRANETICS CORP. 9965 Federal Drive colorado Springs, CO 80921 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P910001 | | Original Filing |
| S117 |
2022-09-23 |
30-day Notice |
| S116 |
2022-06-17 |
Real-time Process |
| S115 |
2022-02-23 |
Real-time Process |
| S114 |
2022-02-14 |
Special (immediate Track) |
| S113 |
2021-03-03 |
Real-time Process |
| S112 | | |
| S111 |
2020-10-19 |
Real-time Process |
| S110 |
2019-09-27 |
30-day Notice |
| S109 |
2018-12-26 |
135 Review Track For 30-day Notice |
| S108 |
2018-10-22 |
30-day Notice |
| S107 |
2018-09-24 |
30-day Notice |
| S106 |
2018-08-30 |
30-day Notice |
| S105 |
2018-07-16 |
30-day Notice |
| S104 |
2018-04-09 |
30-day Notice |
| S103 |
2018-02-28 |
30-day Notice |
| S102 |
2017-11-28 |
30-day Notice |
| S101 | | |
| S100 | | |
| S099 |
2017-08-22 |
30-day Notice |
| S098 |
2017-08-04 |
30-day Notice |
| S097 |
2017-08-03 |
Real-time Process |
| S096 |
2017-07-27 |
30-day Notice |
| S095 |
2017-07-24 |
Special (immediate Track) |
| S094 |
2017-06-30 |
Special (immediate Track) |
| S093 |
2017-05-22 |
30-day Notice |
| S092 |
2017-04-07 |
Special (immediate Track) |
| S091 |
2017-03-09 |
Real-time Process |
| S090 |
2016-12-08 |
30-day Notice |
| S089 |
2016-11-16 |
Real-time Process |
| S088 |
2016-10-04 |
30-day Notice |
| S087 |
2016-06-08 |
Special (immediate Track) |
| S086 |
2016-05-25 |
30-day Notice |
| S085 |
2016-03-14 |
Special (immediate Track) |
| S084 |
2016-03-08 |
30-day Notice |
| S083 |
2016-01-13 |
30-day Notice |
| S082 |
2015-11-25 |
30-day Notice |
| S081 |
2015-11-09 |
30-day Notice |
| S080 |
2015-09-01 |
30-day Notice |
| S079 |
2015-08-28 |
Normal 180 Day Track |
| S078 |
2015-07-22 |
Real-time Process |
| S077 |
2015-01-12 |
30-day Notice |
| S076 |
2014-12-08 |
30-day Notice |
| S075 |
2014-12-08 |
30-day Notice |
| S074 |
2014-11-18 |
30-day Notice |
| S073 |
2014-08-11 |
30-day Notice |
| S072 |
2014-07-14 |
Real-time Process |
| S071 |
2014-04-15 |
Real-time Process |
| S070 |
2014-03-19 |
30-day Notice |
| S069 |
2013-12-17 |
30-day Notice |
| S068 | | |
| S067 |
2013-09-03 |
30-day Notice |
| S066 |
2013-07-22 |
30-day Notice |
| S065 |
2013-04-01 |
Normal 180 Day Track |
| S064 |
2013-01-30 |
30-day Notice |
| S063 |
2012-12-11 |
30-day Notice |
| S062 |
2012-11-27 |
30-day Notice |
| S061 |
2012-08-01 |
30-day Notice |
| S060 |
2012-07-02 |
30-day Notice |
| S059 |
2012-07-02 |
Normal 180 Day Track |
| S058 |
2012-06-25 |
30-day Notice |
| S057 |
2012-06-06 |
30-day Notice |
| S056 |
2012-05-08 |
Real-time Process |
| S055 |
2012-05-01 |
30-day Notice |
| S054 |
2012-04-02 |
30-day Notice |
| S053 |
2012-01-27 |
30-day Notice |
| S052 |
2011-12-02 |
30-day Notice |
| S051 |
2011-11-30 |
135 Review Track For 30-day Notice |
| S050 |
2011-10-07 |
Real-time Process |
| S049 |
2011-08-26 |
Real-time Process |
| S048 |
2011-05-10 |
30-day Notice |
| S047 |
2011-05-09 |
Normal 180 Day Track No User Fee |
| S046 | | |
| S045 |
2011-02-04 |
135 Review Track For 30-day Notice |
| S044 |
2011-02-01 |
30-day Notice |
| S043 |
2011-01-06 |
30-day Notice |
| S042 |
2011-01-03 |
135 Review Track For 30-day Notice |
| S041 |
2010-12-01 |
30-day Notice |
| S040 |
2010-11-22 |
Normal 180 Day Track No User Fee |
| S039 | | |
| S038 |
2010-10-12 |
30-day Notice |
| S037 |
2010-09-15 |
30-day Notice |
| S036 | | |
| S035 | | |
| S034 |
2010-02-18 |
Normal 180 Day Track No User Fee |
| S033 |
2009-09-11 |
Normal 180 Day Track |
| S032 |
2009-06-02 |
Real-time Process |
| S031 |
2009-05-05 |
30-day Notice |
| S030 | | |
| S029 | | |
| S028 |
2008-11-05 |
30-day Notice |
| S027 |
2008-10-30 |
135 Review Track For 30-day Notice |
| S026 |
2006-11-16 |
Normal 180 Day Track |
| S025 |
2006-04-14 |
Real-time Process |
| S024 |
2003-02-10 |
Normal 180 Day Track |
| S023 |
2003-01-31 |
Normal 180 Day Track No User Fee |
| S022 | | |
| S021 |
2002-09-05 |
Normal 180 Day Track |
| S020 |
2001-03-30 |
Normal 180 Day Track |
| S019 |
2000-12-21 |
Normal 180 Day Track |
| S018 |
2000-02-09 |
Normal 180 Day Track |
| S017 |
1999-09-28 |
135 Review Track For 30-day Notice |
| S016 |
1999-06-14 |
Normal 180 Day Track |
| S015 |
1999-03-08 |
Normal 180 Day Track |
| S014 |
1998-08-25 |
Normal 180 Day Track |
| S013 |
1998-03-17 |
Normal 180 Day Track |
| S012 |
1996-11-27 |
Normal 180 Day Track |
| S011 | | |
| S010 |
1994-09-26 |
Normal 180 Day Track |
| S009 |
1994-09-12 |
Normal 180 Day Track |
| S008 |
1994-05-24 |
Normal 180 Day Track |
| S007 |
1994-05-16 |
Normal 180 Day Track |
| S006 |
1993-07-07 |
Normal 180 Day Track |
| S005 |
1993-06-17 |
Normal 180 Day Track |
| S004 | | |
| S003 | | |
| S002 |
1992-09-14 |
Normal 180 Day Track |
| S001 |
1992-06-08 |
Normal 180 Day Track |
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