Emblem S-ICD, Electrode
FDA premarket approval P110042/S120 · decided 2019-02-28
Approval details
- PMA number
- P110042
- Supplement
- S120
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Emblem S-ICD, Electrode
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2018-12-26
- Decision date
- 2019-02-28
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the sales packaging and label changes being made to BSC lead families.
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