PMA P130013S041
- Device
- WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S041
- Product code
- NGV
- Decision date
- 2021-02-10
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- Approval to add a precaution statement to the instructions for use.
Current openFDA PMA Record#
- Device
- WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S041
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2021-02-10
- Decision code
- APPR
- Date received
- 2021-01-11
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to add a precaution statement to the instructions for use.