- Device
- Subcutaneous ICD Devices: EMBLEM S-ICD
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S133
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-04-01
- Decision code
- APPR
- Date received
- 2020-01-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes included in LATITUDE NXT Patient Management System, Release 6.1.5 and associated changes in Server and Communicator software updates.