- Device
- EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) high voltage (HV) Capacitor
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S216
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-10-02
- Decision code
- OK30
- Date received
- 2026-09-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to adjust the manufacturing steps and modify the laser equipment software for the HV capacitors in EMBLEM SICD devices