PMA P110042S211
- Device
- EMBLEM S-ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S211
- Product code
- LWS
- Decision date
- 2026-07-01
- Classification
- Cardiovascular
- 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
- EMBLEM S-ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S211
- 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