EMBLEM, EMBLEM MRI
FDA premarket approval P110042/S116 · decided 2018-11-16
Approval details
- PMA number
- P110042
- Supplement
- S116
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EMBLEM, EMBLEM MRI
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2018-10-19
- Decision date
- 2018-11-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Addition of alternative equipment to sterilize Accolade, NG3, NG4,and EMBLEM S-ICD product families using the new sterilization cycle DEV_PROD55_02 at the Clonmel, Ireland manufacturing facility.
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