Atlas FDA

WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli

FDA premarket approval P130013/S064 · decided 2024-02-05

Approval details

PMA number
P130013
Supplement
S064
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli
Generic name
System, appendage closure, left atrial
Applicant
Boston Scientific Corp
Date received
2023-11-09
Decision date
2024-02-05
Days to decision
88 days
Decision code
APPR
Product code
NGV
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
Statement
Approval for an alternative hemostasis valve for the WATCHMAN FLX and WATCHMAN FLX Pro Delivery Systems.

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