EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator
FDA premarket approval P110042/S143 · decided 2020-10-16
Approval details
- PMA number
- P110042
- Supplement
- S143
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2020-08-13
- Decision date
- 2020-10-16
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval to allow an additional mold release/de-nest agent to be applied to the polyethylene terephthalate glycol (PETG) sheets used to form sterile packaging.
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