PMA P110042S214
- Device
- Emblem S-ICD (A209); Emblem MRI S-ICD (A219)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S214
- Product code
- LWS
- Decision date
- 2026-07-01
- Classification
- Cardiovascular
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- adding two alternative suppliers of high purity titanium raw material
Current openFDA PMA Record#
- Device
- Emblem S-ICD (A209); Emblem MRI S-ICD (A219)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S214
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2026-07-01
- Decision code
- OK30
- Date received
- 2026-06-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding two alternative suppliers of high purity titanium raw material