- Device
- EMBLEM subcutaneous implantable cardioverter defibrillation (S-ICD) Programmer, EMBLEM Pulse Generator (PG)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S164
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-12-17
- Decision code
- APPR
- Date received
- 2021-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes for the EMBLEM S-ICD and Programmer SW Application Models 2877 and 3877, and firmware changes for the EMBLEM Pulse Generator.