EMBLEM Programmer
FDA premarket approval P110042/S123 · decided 2019-05-21
Approval details
- PMA number
- P110042
- Supplement
- S123
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EMBLEM Programmer
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-03-04
- Decision date
- 2019-05-21
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for updates to the programmer software and minor labeling changes.
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