FDA.reportPublic FDA data

PMA P130013S056

Device
WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System
Applicant
Boston Scientific Corp
PMA number
P130013
Supplement
S056
Product code
NGV
Decision date
2023-01-20
Generic name
System, appendage closure, left atrial
Approval order statement
Approval for an increase in the filter fabric length for each device size along with several other associated minor changes related to the increase in fabric length.

Current openFDA PMA Record#

Device
WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System
Applicant
Boston Scientific Corp
PMA number
P130013
Supplement
S056
Product code
NGV
Generic name
System, appendage closure, left atrial
Decision date
2023-01-20
Decision code
APPR
Date received
2022-10-25
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for an increase in the filter fabric length for each device size along with several other associated minor changes related to the increase in fabric length.