EMBLEM S-ICD Pulse Generator (PG), EMBLEM MRI S-ICD Pulse Generator (PG)
FDA premarket approval P110042/S110 · decided 2018-06-19
Approval details
- PMA number
- P110042
- Supplement
- S110
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EMBLEM S-ICD Pulse Generator (PG), EMBLEM MRI S-ICD Pulse Generator (PG)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2018-05-22
- Decision date
- 2018-06-19
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Introduction of new Encapsulation and Curing Steps and modified inspection steps for S-ICD manufacturing.
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