Model A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App
FDA premarket approval P110042/S080 · decided 2017-05-19
Approval details
- PMA number
- P110042
- Supplement
- S080
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Model A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2017-03-27
- Decision date
- 2017-05-19
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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.
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