- Device
- S-ICD EMBLEM™ GEN 2 (A209); S-ICD EMBLEM™ MRI (A219)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S215
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-07-23
- Decision code
- OK30
- Date received
- 2026-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add a functionally equivalent alternate vapor degreasing solvent used to remove contaminants from pulse generator components