PMA P110042S043
- Device
- EMBLEM S ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S043
- Product code
- LWS
- Decision date
- 2015-03-13
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE EMBLEM S-ICD SYSTEM.
Current openFDA PMA Record#
- Device
- EMBLEM S ICD SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S043
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2015-03-13
- Decision code
- APPR
- Date received
- 2014-11-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE EMBLEM S-ICD SYSTEM.