- Device
- EMBLEM Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S138
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-05-28
- Decision code
- OK30
- Date received
- 2020-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce a human visual inspection acceptance activity for the terminal ring empty lumen component to detect cracks in the S-ICD Lead.