PMA P910077
- Device
- LATITUDE™ NXT Remote Patient Management System; LATITUDE™ NXT System Server Software Model 6460
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S190
- Product code
- LWS
- Decision date
- 2026-07-01
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- software changes for the LATITUDE NXT Patient Management System, Release 7.8
Current openFDA PMA Record#
- Device
- LATITUDE™ NXT Remote Patient Management System; LATITUDE™ NXT System Server Software Model 6460
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S198
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (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