- Device
- EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S155
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-04-02
- Decision code
- OK30
- Date received
- 2021-03-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier for the Grade 1 Titanium raw material used in manufacturing of the EMBLEM S-ICD case halves component.