PMA P130013S069

Device: WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S069
Product code: NGV
Decision date: 2024-06-14
Classification: Cardiovascular
Generic name: System, appendage closure, left atrial
Approval order statement: to add an alternate supplier for the tantalum marker material for the Watchman FLX Pro LAAC implant

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: S069
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2024-06-14
Decision code: OK30
Date received: 2024-05-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to add an alternate supplier for the tantalum marker material for the Watchman FLX Pro LAAC implant