Atlas FDA

WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System

FDA premarket approval P130013/S056 · decided 2023-01-20

Approval details

PMA number
P130013
Supplement
S056
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
WATCHMAN FLX™ Left Atrial Appendage Closure Device with Delivery System
Generic name
System, appendage closure, left atrial
Applicant
Boston Scientific Corp
Date received
2022-10-25
Decision date
2023-01-20
Days to decision
87 days
Decision code
APPR
Product code
NGV
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
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.

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