PMA P130013S039
- Device
- WATCHMAN Left Atrial Appendage Closure Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S039
- Product code
- NGV
- Decision date
- 2020-12-16
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- Approval for an alternative packaging configuration change for WATCHMAN LAA Closure Device and Delivery System
Current openFDA PMA Record#
- Device
- WATCHMAN Left Atrial Appendage Closure Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S039
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2020-12-16
- Decision code
- APPR
- Date received
- 2020-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternative packaging configuration change for WATCHMAN LAA Closure Device and Delivery System