PMA P130013S071

Device: WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S071
Product code: NGV
Decision date: 2025-04-25
Classification: Cardiovascular
Generic name: System, appendage closure, left atrial
Approval order statement: Approval for updated inspection criteria used for the WATCHMAN FLX and WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device distal tine attachment process.

Current openFDA PMA Record#

Device: WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl
Applicant: Boston Scientific Corp
PMA number: P130013
Supplement: S071
Product code: NGV
Generic name: System, appendage closure, left atrial
Decision date: 2025-04-25
Decision code: APPR
Date received: 2024-09-24
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for updated inspection criteria used for the WATCHMAN FLX and WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device distal tine attachment process.