PMA P130013S055

Device: WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S055
Product code: NGV
Decision date: 2022-11-07
Generic name: System, appendage closure, left atrial
Approval order statement: Move portions of the component level manufacturing into a new building at the Maple Grove, Minnesota BSC site.

Current openFDA PMA Record#

Device: WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S055
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2022-11-07
Decision code: OK30
Date received: 2022-10-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Move portions of the component level manufacturing into a new building at the Maple Grove, Minnesota BSC site.