PMA P130013S018
- Device
- WATCHMAN Left Atrial Appendage CLosure (LAAC) Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S018
- Product code
- NGV
- Decision date
- 2018-03-19
- Classification
- System, Appendage Closure, Left Atrial
- Generic name
- System, appendage closure, left atrial
- Approval order statement
- Addition of an alternate dowel pin for use in the WATCHMAN implant.
Current openFDA PMA Record#
- Device
- WATCHMAN Left Atrial Appendage CLosure (LAAC) Device with Delivery System
- Applicant
- Boston Scientific Corp
- PMA number
- P130013
- Supplement
- S018
- Product code
- NGV
- Generic name
- System, appendage closure, left atrial
- Decision date
- 2018-03-19
- Decision code
- OK30
- Date received
- 2018-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate dowel pin for use in the WATCHMAN implant.