FDA.reportPublic FDA data

PMA P130013S059

Device
WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System
Applicant
Boston Scientific Corp
PMA number
P130013
Supplement
S059
Product code
NGV
Decision date
2023-10-31
Classification
Cardiovascular
Generic name
System, appendage closure, left atrial
Approval order statement
Approval of the protocol (amended via email on October 26, 2023) for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P130013/S057.

Current openFDA PMA Record#

Device
WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System
Applicant
Boston Scientific Corp
PMA number
P130013
Supplement
S059
Product code
NGV
Generic name
System, appendage closure, left atrial
Decision date
2023-10-31
Decision code
APPR
Date received
2023-09-20
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the protocol (amended via email on October 26, 2023) for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P130013/S057.