Identity
- Trade Name
- DYNAGEN™ EL ICD VR FDA UDI
- Generic Name
- Single-chamber implantable defibrillator FDA UDI
- Device Name
- Implantable Cardioverter Defibrillator VR FDA UDI
- Model / Reference
- D151 FDA UDI
- Description
- Implantable Cardioverter Defibrillator VR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00802526534300 FDA UDI
- PMA Number
- P960040 FDA UDI
- FDA Product Code
- LWS FDA UDI
- GMDN Term
- Single-chamber implantable defibrillator 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: Single-chamber implantable defibrillator
Dynagen™ El Icd Vr by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Single-chamber implantable defibrillator.
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Cleared under the same submission
P960040 also covers:
- DYNAGEN™ EL ICD DR — Boston Scientific
- DYNAGEN™ EL ICD DR — Boston Scientific
- DYNAGEN™ EL ICD VR — Boston Scientific
- DYNAGEN™ MINI ICD DR — Boston Scientific
- DYNAGEN™ MINI ICD DR — Boston Scientific
- DYNAGEN™ MINI ICD VR — Boston Scientific
- DYNAGEN™ MINI ICD VR — Boston Scientific
- ENERGEN™ ICD — Boston Scientific
- ENERGEN™ ICD — Boston Scientific
- ENERGEN™ ICD — Boston Scientific
- ENERGEN™ ICD — Boston Scientific
- INCEPTA™ ICD — 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 77a698a2-e897-4326-ad21-315f1dc48d59 34 fields · synced May 31, 2026