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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceWatchman Left Atrial Appendage Closure (LAAC) Device with Delivery System
Generic NameSystem, appendage closure, left atrial
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP130013
Supplement NumberS025
Date Received12/07/2018
Decision Date03/01/2019
Product Code NGV 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for approval for a manufacturing site, Synergy Health Ireland Ltd., (a STERIS Company), located at IDA Business and Technology Park, Srah, Tullamore, County Offaly, Ireland, as a new ethylene oxide (EO) sterilization site for the WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System.
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