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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
Generic Namesystem, appendage closure, left atrial
ApplicantBoston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP130013
Supplement NumberS010
Date Received06/16/2016
Decision Date06/28/2016
Product Code NGV 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of an alternate material and supplier for the suture component of the device.
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