EMBLEM S-ICD VI Electrode (Lead)
FDA premarket approval P110042/S192 · decided 2023-12-08
Approval details
- PMA number
- P110042
- Supplement
- S192
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- EMBLEM S-ICD VI Electrode (Lead)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-11-08
- Decision date
- 2023-12-08
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- approval of the revised protocol for the EMBLEM S-ICD Electrode Model 3501 PAS
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