PMA P110042S169
- Device
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S169
- Product code
- LWS
- Decision date
- 2022-05-18
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for updated labeling to include a clinical summary for the S-ICD Post Approval Study.
Current openFDA PMA Record#
- Device
- Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S169
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-05-18
- Decision code
- APPR
- Date received
- 2022-04-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated labeling to include a clinical summary for the S-ICD Post Approval Study.