- 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
- S090
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2026-08-28
- Decision code
- OK30
- Date received
- 2026-07-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of semi-automated Robot Assisted Disassembly equipment to be used as an alternative equipment to the existing manual unload fixture to automate the Intermediate Expansion Disassembly step for WATCHMAN FLX and WATCHMAN FLX Pro 24mm implants that are expanded using the Technology Development Project tool set