PMA N970003S266
- Device
- ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S266
- Product code
- LWP
- Decision date
- 2021-09-17
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for the software modifications to the LATITUDE NXT Remote Patient Management System.
Current openFDA PMA Record#
- Device
- ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S266
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-09-17
- Decision code
- APPR
- Date received
- 2021-06-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the software modifications to the LATITUDE NXT Remote Patient Management System.