EMBLEM S-ICD System
FDA premarket approval P110042/S132 · decided 2020-03-20
Approval details
- PMA number
- P110042
- Supplement
- S132
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EMBLEM S-ICD System
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-12-23
- Decision date
- 2020-03-20
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for alternate hardware components and design modifications (with associated manufacturing changes), firmware update to version 3.1.543 (Models A209/A219), and software to version 4.08 (Model 2877).
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