EMBLEM S-ICD PG Models A209 and A219
FDA premarket approval P110042/S118 · decided 2018-11-29
Approval details
- PMA number
- P110042
- Supplement
- S118
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EMBLEM S-ICD PG Models A209 and A219
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2018-11-27
- Decision date
- 2018-11-29
- Days to decision
- 2 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Add AT&S Korea as a second supplier of the dump resistor component.
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