PMA P110042S154
- Device
- EMBLEM S-ICD Lead
- Applicant
- Boston Scientific Corporation
- Product code
- LWS
- Decision date
- 2021-06-10
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for changes addressing lead fractures and the addition of a third sterilization chamber.
Current openFDA PMA Record#
- Device
- EMBLEM S-ICD Lead
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S154
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-06-10
- Decision code
- APPR
- Date received
- 2021-03-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes addressing lead fractures and the addition of a third sterilization chamber.