Identity
- Trade Name
- EMBLEM™ S-ICD FDA UDI
- Generic Name
- Endocardial defibrillation lead FDA UDI
- Device Name
- Subcutaneous Electrode FDA UDI
- Model / Reference
- 3501 FDA UDI
- Description
- Subcutaneous Electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00802526599200 FDA UDI
- PMA Number
- P110042 FDA UDI
- FDA Product Code
- LWS FDA UDI
- GMDN Term
- Endocardial defibrillation lead FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Endocardial defibrillation lead
Emblem™ S-Icd by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endocardial defibrillation lead.
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- Pamira SD 65/18 — BIOTRONIK SE & Co. KG · Class III
- Durata™ — ST. JUDE MEDICAL, INC. · Class III
- Plexa ProMRI SD 60/16 — BIOTRONIK SE & Co. KG · Class III
- D2-Kit — BIOTRONIK SE & Co. KG · Class III
- Durata™ — ST. JUDE MEDICAL, INC. · Class III
Cleared under the same submission
P110042 also covers:
- EMBLEM™ MRI S-ICD — Boston Scientific
- EMBLEM™ S-ICD — Boston Scientific
- EMBLEM™ S-ICD — Boston Scientific
- EMBLEM™ S-ICD — Boston Scientific
- EMBLEM™ S-ICD Electrode Delivery System — Boston Scientific
- EMBLEM™ S-ICD Programmer — Boston Scientific
- EMBLEM™ S-ICD Programmer — Boston Scientific
- EMBLEM™ S-ICD Programmer — Boston Scientific
- EMBLEM™ S-ICD Programmer — Boston Scientific
- EMBLEM™ S-ICD Programmer — Boston Scientific
- EMBLEM™ S-ICD Programmer — Boston Scientific
- EMBLEM™ S-ICD Subcutaneous Electrode Insertion Tool — Boston Scientific
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI 88bb440d-a2ee-4441-bf01-ede1ff883db4 35 fields · synced May 31, 2026