CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOCOOL, CELSIUS

FDA Premarket Approval P950005 S079

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 procedure to repackage and relabel products with secondary packaging damage

DeviceCELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOCOOL, CELSIUS
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantBiosense Webster, Inc
Date Received2021-04-12
Decision Date2021-04-27
PMAP950005
SupplementS079
Product CodeLPB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Biosense Webster, Inc 31 Technology Drive suite 200 irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P950005Original Filing
S079 2021-04-12 30-day Notice
S078 2021-03-31 30-day Notice
S077 2021-03-02 Special (immediate Track)
S076 2021-01-28 30-day Notice
S075 2020-09-15 30-day Notice
S074 2020-03-13 30-day Notice
S073 2020-01-16 30-day Notice
S072 2019-07-30 30-day Notice
S071 2019-02-12 30-day Notice
S070 2018-07-02 30-day Notice
S069 2017-11-27 135 Review Track For 30-day Notice
S068 2017-10-03 30-day Notice
S067 2017-09-11 30-day Notice
S066 2017-06-30 30-day Notice
S065 2017-06-29 30-day Notice
S064 2017-06-02 135 Review Track For 30-day Notice
S063 2016-11-28 135 Review Track For 30-day Notice
S062 2016-08-26 30-day Notice
S061 2016-06-13 Normal 180 Day Track
S060 2016-03-31 30-day Notice
S059 2015-10-09 30-day Notice
S058 2015-07-17 30-day Notice
S057 2015-05-06 30-day Notice
S056 2015-02-20 30-day Notice
S055 2014-11-14 30-day Notice
S054 2014-09-29 Real-time Process
S053 2014-09-22 30-day Notice
S052 2014-08-14 30-day Notice
S051 2014-07-02 Normal 180 Day Track No User Fee
S050 2014-04-03 135 Review Track For 30-day Notice
S049 2013-12-27 30-day Notice
S048 2013-10-18 30-day Notice
S047 2013-11-01 Real-time Process
S046 2013-09-13 30-day Notice
S045 2013-08-09 30-day Notice
S044 2013-04-26 30-day Notice
S043 2013-03-27 30-day Notice
S042 2013-03-21 135 Review Track For 30-day Notice
S041 2012-11-07 Normal 180 Day Track
S040 2012-09-25 30-day Notice
S039 2012-06-19 30-day Notice
S038 2012-06-19 Normal 180 Day Track
S037 2012-04-16 Normal 180 Day Track
S036 2011-11-21 30-day Notice
S035 2011-08-29 30-day Notice
S034 2011-03-01 30-day Notice
S033 2011-03-01 135 Review Track For 30-day Notice
S032 2011-01-31 30-day Notice
S031 2010-10-27 Normal 180 Day Track No User Fee
S030 2010-03-02 Normal 180 Day Track No User Fee
S029 2010-02-12 30-day Notice
S028 2009-09-28 Real-time Process
S027
S026 2009-04-15 30-day Notice
S025 2009-02-18 Normal 180 Day Track
S024 2007-12-14 Normal 180 Day Track No User Fee
S023 2007-10-04 30-day Notice
S022 2007-09-28 Real-time Process
S021 2007-07-24 30-day Notice
S020 2006-01-26 30-day Notice
S019 2005-09-06 Normal 180 Day Track
S018 2004-09-28 Normal 180 Day Track
S017 2003-01-02 Real-time Process
S016 2002-06-07 Real-time Process
S015 2002-04-17 Normal 180 Day Track
S014 2001-05-29 Normal 180 Day Track
S013 2001-05-23 Real-time Process
S012 2001-04-13 Normal 180 Day Track
S011 2001-02-21 Normal 180 Day Track
S010 2000-12-08 Normal 180 Day Track
S009 2000-07-31 Normal 180 Day Track
S008 2000-04-19 Normal 180 Day Track
S007 1999-11-26 Real-time Process
S006 1999-08-02
S005
S004 1999-02-22 Real-time Process
S003 1998-07-27 Normal 180 Day Track
S002 1998-03-23 Normal 180 Day Track
S001 1997-11-10 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
10846835005592 P950005 000
10846835005073 P950005 000
10846835000405 P950005 000
10846835006575 P950005 002
10846835006551 P950005 002
10846835006520 P950005 002
10846835006513 P950005 002
10846835006506 P950005 002
10846835006476 P950005 002
10846835006599 P950005 002
10846835006605 P950005 002
10846835006681 P950005 002
10846835006674 P950005 002
10846835006667 P950005 002
10846835006643 P950005 002
10846835006636 P950005 002
10846835006612 P950005 002
10846835006452 P950005 002
10846835006483 P950005 004
10846835006469 P950005 004

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