- Device
- EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S137
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-07-07
- Decision code
- APPR
- Date received
- 2020-04-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Model 3877 Programmer SW Application v1.01, updated telemetry firmware for Model 3300 LATITUDE Programmer to support communication with S-ICD devices, and other minor changes.