EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Pulse Generator (PG)
FDA premarket approval P110042/S198 · decided 2024-09-25
Approval details
- PMA number
- P110042
- Supplement
- S198
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Pulse Generator (PG)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corporation
- Date received
- 2024-08-30
- Decision date
- 2024-09-25
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- relocating an optional rework test ("E1 Test (Scrubber)") from the Final Pack Rework workflow to a upstream PG assembly workflow
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