ELCA Coronary Atherectomy Catheter

FDA Premarket Approval P910001 S113

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 for changing the device’s labeling, specifically, the wording of a precaution statement in the instructions for use.

DeviceELCA Coronary Atherectomy Catheter
Generic NameDevice, Angioplasty, Laser, Coronary
ApplicantSPECTRANETICS CORP.
Date Received2021-03-03
Decision Date2021-05-11
PMAP910001
SupplementS113
Product CodeLPC 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address SPECTRANETICS CORP. 9965 Federal Drive colorado Springs, CO 80921

Supplemental Filings

Supplement NumberDateSupplement Type
P910001Original Filing
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

NIH GUDID Devices

Device IDPMASupp
M204117205AA0 P910001 000
00813132025427 P910001 000
M204120008AA0 P910001 012
00813132025410 P910001 012
00813132025403 P910001 014
00813132025434 P910001 014
00813132025441 P910001 014
M204117016AA0 P910001 014
M204114009AA0 P910001 014
M204120009AA0 P910001 014
M204110002AA0 P910001 015
00813132025489 P910001 015
M204110001AA0 P910001 015
00813132025465 P910001 018
M204110003AA0 P910001 018
00813132025458 P910001 019
M204110004AA0 P910001 019
00813132025472 P910001 019

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