SmartAblate Irrigation Tubing Set

FDA Premarket Approval P990071 S045

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

To update the parameters of an in-process quality control leak test

DeviceSmartAblate Irrigation Tubing Set
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantBIOSENSE WEBSTER, INC.
Date Received2020-09-08
Decision Date2020-10-01
PMAP990071
SupplementS045
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. 33 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P990071Original Filing
S045 2020-09-08 30-day Notice
S044 2020-04-20 Normal 180 Day Track
S043 2020-03-13 30-day Notice
S042 2019-01-03 Real-time Process
S041 2018-07-02 30-day Notice
S040 2018-06-20 Normal 180 Day Track No User Fee
S039 2018-05-21 Special (immediate Track)
S038 2017-10-03 30-day Notice
S037 2017-09-11 Normal 180 Day Track
S036 2017-06-02 Real-time Process
S035 2017-05-23 Special (immediate Track)
S034 2016-06-13 Normal 180 Day Track
S033 2016-05-09 Normal 180 Day Track
S032 2015-08-17 Special (immediate Track)
S031 2015-05-18 30-day Notice
S030 2014-11-10 30-day Notice
S029 2014-09-10 Real-time Process
S028 2014-07-02 Normal 180 Day Track No User Fee
S027 2014-04-07 Normal 180 Day Track
S026
S025 2013-12-27 30-day Notice
S024 2013-08-09 30-day Notice
S023 2013-04-29 Real-time Process
S022 2013-03-27 30-day Notice
S021
S020 2012-08-17 Real-time Process
S019 2012-06-19 30-day Notice
S018 2012-06-19 Normal 180 Day Track
S017 2012-04-16 Normal 180 Day Track
S016 2012-01-04 Normal 180 Day Track
S015 2011-08-29 30-day Notice
S014
S013 2011-06-20 Normal 180 Day Track
S012 2011-03-01 30-day Notice
S011 2010-03-17 Special (immediate Track)
S010 2010-03-02 Normal 180 Day Track No User Fee
S009 2010-01-15 Normal 180 Day Track
S008 2006-03-01 Real-time Process
S007 2005-04-11 Normal 180 Day Track
S006 2005-02-17 Special (immediate Track)
S005 2003-12-22 Normal 180 Day Track
S004 2003-11-05 Real-time Process
S003 2002-10-01 Real-time Process
S002 2001-11-29 Normal 180 Day Track
S001 2000-06-28 Normal 180 Day Track

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