PMA P110042S080
- Device
- Model A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S080
- Product code
- LWS
- Decision date
- 2017-05-19
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for a firmware update to version 3.1.536 on the EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219 devices, and software version 4.03 for the Model 2877 Programmer Software.
Current openFDA PMA Record#
- Device
- Model A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S080
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-05-19
- Decision code
- APPR
- Date received
- 2017-03-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a firmware update to version 3.1.536 on the EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219 devices, and software version 4.03 for the Model 2877 Programmer Software.