SLS SPECTRANETICS LASER SHEATHS

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Premarket Approval P960042 S034

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

Remove redundant quality control inspection steps in your fiber draw and fiber re-spooling manufacturing processes.

DeviceSLS SPECTRANETICS LASER SHEATHS
Classification NameDevice, Removal, Pacemaker Electrode, Percutaneous
Generic NameDevice, Removal, Pacemaker Electrode, Percutaneous
ApplicantSPECTRANETICS CORP.
Date Received2012-01-27
Decision Date2012-02-24
PMAP960042
SupplementS034
Product CodeMFA
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address SPECTRANETICS CORP. 96 Talamine Ct. colorado Springs, CO 80907-5159

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
S044
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
S024
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
S018
S017 2010-06-15 30-day Notice
S016
S015
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
S011
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

NIH GUDID Devices

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

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