Identity
- Trade Name
- INCEPTA™ CRT-D FDA UDI
- Generic Name
- Dual-chamber implantable defibrillator FDA UDI
- Device Name
- Cardiac Resynchronization Therapy Defibrillator FDA UDI
- Model / Reference
- N164 FDA UDI
- Description
- Cardiac Resynchronization Therapy Defibrillator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00802526481031 FDA UDI
- PMA Number
- P010012 FDA UDI
- FDA Product Code
- LWP FDA UDI
- GMDN Term
- Dual-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
Category: Dual-chamber implantable defibrillator
Incepta™ Crt-D by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P010012 also covers:
- ACUITY™ Spiral — Boston Scientific
- ACUITY™ Spiral — Boston Scientific
- ACUITY™ Spiral — Boston Scientific
- ACUITY™ X4 Flushing tool/Wire guide — Boston Scientific
- ACUITY™ X4 Spiral L — Boston Scientific
- ACUITY™ X4 Spiral L — Boston Scientific
- ACUITY™ X4 Spiral S — Boston Scientific
- ACUITY™ X4 Spiral S — Boston Scientific
- ACUITY™ X4 Straight — Boston Scientific
- ACUITY™ X4 Straight — Boston Scientific
- DYNAGEN™ CRT-D — Boston Scientific
- DYNAGEN™ CRT-D — 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 7ec2d8ef-d0a0-4dca-8078-57931c7458ab 34 fields · synced May 30, 2026