- Device
- EMBLEM S-ICD System
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S132
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-03-20
- Decision code
- APPR
- Date received
- 2019-12-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for alternate hardware components and design modifications (with associated manufacturing changes), firmware update to version 3.1.543 (Models A209/A219), and software to version 4.08 (Model 2877).