Biosense Webster Cables

FDA Premarket Approval P990071 S052

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 add an alternate sterilization site

DeviceBiosense Webster Cables
Generic NameCardiac Ablation Percutaneous Catheter
ApplicantBIOSENSE WEBSTER, INC.
Date Received2021-08-23
Decision Date2021-09-22
PMAP990071
SupplementS052
Product CodeLPB 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation 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
P990071Original Filing
S052 2021-08-23 Normal 180 Day Track No User Fee
S051
S050 2021-06-11 30-day Notice
S049 2021-04-12 30-day Notice
S048 2021-03-31 30-day Notice
S047
S046
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

NIH GUDID Devices

Device IDPMASupp
10846835002393 P990071 000
10846835002386 P990071 000
10846835002379 P990071 000
10846835000016 P990071 005
10846835000085 P990071 005
10846835012644 P990071 017
10846835012637 P990071 017
10846835009743 P990071 017

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