WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure with Delivery System

FDA Premarket Approval P130013 S041

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 to add a precaution statement to the instructions for use.

DeviceWATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure with Delivery System
Generic NameSystem, Appendage Closure, Left Atrial
ApplicantBoston Scientific Corp.
Date Received2021-01-11
Decision Date2021-02-10
PMAP130013
SupplementS041
Product CodeNGV 
Advisory CommitteeCardiovascular
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. one Scimed Place maple Grove, MN 55311-1566

Supplemental Filings

Supplement NumberDateSupplement Type
P130013Original Filing
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

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