- Device
- BSC WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S038
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2021-03-24
- Decision code
- APPR
- Date received
- 2020-08-05
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in composition to the detergent that is used in the cleaning of the subject device during its manufacturing process