PMA N970003S307
- Device
- ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S307
- Product code
- LWP
- Decision date
- 2026-07-01
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- software changes for the LATITUDE NXT Patient Management System, Release 7.8
Current openFDA PMA Record#
- Device
- ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S307
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-07-01
- Decision code
- APPR
- Date received
- 2026-04-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- software changes for the LATITUDE NXT Patient Management System, Release 7.8