WATCHMAN FLX Left Atrial Appendage Closure System

FDA Premarket Approval P130013 S047

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

DeviceWATCHMAN FLX Left Atrial Appendage Closure System
Generic NameSystem, Appendage Closure, Left Atrial
ApplicantBoston Scientific Corp.one Scimed Placemaple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS047 Date Received04/07/2022 Decision Date05/06/2022 Product Code NGV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-07
Decision Date2022-05-06
PMAP130013
SupplementS047
Product CodeNGV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBoston Scientific Corp.
one Scimed Place
maple Grove, MN 55311-1566 PMA NumberP130013 Supplement NumberS047 Date Received04/07/2022 Decision Date05/06/2022 Product Code NGV  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Process Devices Using The Reduced EtO S756 Sterilization Cycle At The BSC Coventry Rhode Island, BSC Galway Ireland, And Steris Tullamore Ireland Facilities

Supplemental Filings

Supplement NumberDateSupplement Type
P130013Original Filing
S056 2022-10-25 Real-time Process
S055 2022-10-18 30-day Notice
S054 2022-09-29 Normal 180 Day Track No User Fee
S053
S052
S051 2022-07-19 30-day Notice
S050
S049 2022-06-22 30-day Notice
S048 2022-04-19 30-day Notice
S047 2022-04-07 30-day Notice
S046 2021-08-26 30-day Notice
S045 2021-07-30 30-day Notice
S044 2021-05-10 30-day Notice
S043
S042 2021-03-03 Normal 180 Day Track No User Fee
S041 2021-01-11 Special (immediate Track)
S040 2020-12-03 30-day Notice
S039 2020-09-30 Real-time Process
S038
S037 2020-03-12 30-day Notice
S036 2020-01-31 30-day Notice
S035
S034 2019-11-12 30-day Notice
S033 2019-07-23 Real-time Process
S032 2019-06-25 30-day Notice
S031
S030 2019-06-03 30-day Notice
S029 2019-05-17 30-day Notice
S028 2019-03-26 30-day Notice
S027 2019-02-01 30-day Notice
S026 2019-01-22 30-day Notice
S025 2018-12-07 Normal 180 Day Track No User Fee
S024 2018-11-16 30-day Notice
S023 2018-11-14 30-day Notice
S022 2018-11-05 30-day Notice
S021
S020 2018-09-17 Real-time Process
S019 2018-02-21 Real-time Process
S018 2018-02-20 30-day Notice
S017 2017-12-15 Real-time Process
S016 2017-11-16 30-day Notice
S015 2017-08-30 30-day Notice
S014 2017-06-27 30-day Notice
S013 2017-03-17 30-day Notice
S012 2017-02-16 30-day Notice
S011 2016-11-15 30-day Notice
S010 2016-06-16 Real-time Process
S009 2016-05-19 Normal 180 Day Track No User Fee
S008 2016-04-05 Normal 180 Day Track No User Fee
S007 2016-04-05 30-day Notice
S006 2016-03-08 30-day Notice
S005 2015-08-21 Special (immediate Track)
S004 2015-08-12 Normal 180 Day Track No User Fee
S003 2015-08-07 30-day Notice
S002 2015-05-07 30-day Notice
S001 2015-04-10 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
08714729838210 P130013 000
08714729838227 P130013 000
08714729838234 P130013 000
08714729838241 P130013 000
08714729838258 P130013 000
08714729838265 P130013 000
08714729838197 P130013 000
08714729838203 P130013 000
08714729860488 P130013 035
08714729860495 P130013 035
08714729860501 P130013 035
08714729860518 P130013 035
08714729860525 P130013 035
00191506004637 P130013 057
00191506004620 P130013 057
00191506004613 P130013 057
00191506004606 P130013 057
00191506004590 P130013 057
00191506004583 P130013 057

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