WATCHMAN Left Atrial Appendage Closure and Delivery System, WATCHMAN Access System

FDA Premarket Approval P130013 S036

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 reduce ethylene oxide sterilization concentrations and increase maximum density for a sterilization load at specified cycles/chambers in steris tullamore and steris minnesota

DeviceWATCHMAN Left Atrial Appendage Closure and Delivery System, WATCHMAN Access System
Generic NameSystem, Appendage Closure, Left Atrial
ApplicantBoston Scientific Corp.
Date Received2020-01-31
Decision Date2020-02-27
PMAP130013
SupplementS036
Product CodeNGV 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
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
08714729838203 P130013 000
08714729838197 P130013 000
08714729838265 P130013 000
08714729838258 P130013 000
08714729838241 P130013 000
08714729838234 P130013 000
08714729838227 P130013 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.