Glidelight Laser Sheath

FDA Premarket Approval P960042 S070

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 the philips laser system and for inclusion of the philips laser system as a compatible device within the labeling for the elca (p910001), and spectranetics laser sheath (sls) and glidelight laser sheath (p960042) devices

DeviceGlidelight Laser Sheath
Generic NameDevice, Removal, Pacemaker Electrode, Percutaneous
ApplicantSpectranetics (Philips)
Date Received2021-01-25
Decision Date2021-09-02
Product CodeMFA 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Spectranetics (Philips) 9965 Federal Drive colorado Springs, CO 80921

Supplemental Filings

Supplement NumberDateSupplement Type
P960042Original Filing
S070 2021-01-25 Normal 180 Day Track
S069 2020-04-06 30-day Notice
S068 2019-09-27 30-day Notice
S067 2019-09-09 30-day Notice
S066 2019-06-07 30-day Notice
S065 2018-10-22 30-day Notice
S064 2018-09-24 30-day Notice
S063 2018-07-16 30-day Notice
S062 2018-06-08 Special (immediate Track)
S061 2018-05-01 30-day Notice
S060 2018-04-09 30-day Notice
S059 2017-07-18 30-day Notice
S058 2017-06-30 Special (immediate Track)
S057 2017-04-10 30-day Notice
S056 2017-04-07 Special (immediate Track)
S055 2016-12-08 30-day Notice
S054 2016-05-25 30-day Notice
S053 2016-03-14 Special (immediate Track)
S052 2015-11-09 30-day Notice
S051 2014-12-08 30-day Notice
S050 2014-10-01 30-day Notice
S049 2014-07-14 Real-time Process
S048 2014-03-19 30-day Notice
S047 2013-12-17 30-day Notice
S046 2013-01-30 30-day Notice
S045 2012-11-27 30-day Notice
S043 2012-11-07 Normal 180 Day Track
S042 2012-10-01 Special (immediate Track)
S041 2012-08-01 30-day Notice
S040 2012-07-02 30-day Notice
S039 2012-06-25 30-day Notice
S038 2012-05-01 30-day Notice
S037 2012-04-10 Real-time Process
S036 2012-04-05 Real-time Process
S035 2012-04-02 30-day Notice
S034 2012-01-27 30-day Notice
S033 2011-12-02 30-day Notice
S032 2011-11-30 135 Review Track For 30-day Notice
S031 2011-09-06 Normal 180 Day Track
S030 2011-05-10 30-day Notice
S029 2011-05-09 Normal 180 Day Track No User Fee
S028 2011-02-07 30-day Notice
S027 2011-02-04 135 Review Track For 30-day Notice
S026 2011-02-01 30-day Notice
S025 2011-01-10 30-day Notice
S023 2010-11-22 Normal 180 Day Track No User Fee
S022 2010-10-12 30-day Notice
S021 2010-08-16 30-day Notice
S020 2010-08-16 30-day Notice
S019 2010-08-02 30-day Notice
S017 2010-06-15 30-day Notice
S014 2009-06-02 Real-time Process
S013 2009-05-05 30-day Notice
S012 2009-04-01 Normal 180 Day Track No User Fee
S010 2008-10-30 135 Review Track For 30-day Notice
S009 2006-04-14 Real-time Process
S008 2002-01-17 Normal 180 Day Track
S007 2001-07-26 Normal 180 Day Track
S006 2000-08-11 Normal 180 Day Track
S005 1999-09-28 135 Review Track For 30-day Notice
S004 1999-02-17 Normal 180 Day Track
S003 1998-08-14 Normal 180 Day Track
S002 1998-03-09 Normal 180 Day Track
S001 1997-12-12 Normal 180 Day Track


Device IDPMASupp
M204500001AA0 P960042 000
M204500013AA0 P960042 002
M204500012AA0 P960042 002
M204500303AA0 P960042 031
M204500302AA0 P960042 031
M204500301AA0 P960042 031

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