PMA P130013S046
- Device
- WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S046
- Product code
- NGV
- Decision date
- 2021-09-09
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- Modification to the implant frame measurement system software used for dimensional inspection.
Current openFDA PMA Record#
- Device
- WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S046
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2021-09-09
- Decision code
- OK30
- Date received
- 2021-08-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the implant frame measurement system software used for dimensional inspection.