Identity
- Trade Name
- DYNAGEN™ CRT-D FDA UDI
- Generic Name
- Cardiac resynchronization therapy implantable defibrillator FDA UDI
- Device Name
- Cardiac Resynchronization Therapy Defibrillator FDA UDI
- Model / Reference
- G154 FDA UDI
- Description
- Cardiac Resynchronization Therapy Defibrillator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00802526534652 FDA UDI
- PMA Number
- P010012 FDA UDI
- FDA Product Code
- NIK FDA UDI
- GMDN Term
- Cardiac resynchronization therapy 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: Cardiac resynchronization therapy implantable defibrillator
Dynagen™ Crt-D by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac resynchronization therapy implantable defibrillator.
- Viva™ Quad XT CRT-D — MEDTRONIC, INC. · Class III
- Amplia MRI™ Quad CRT-D SureScan™ — MEDTRONIC, INC. · Class III
- Neutrino™ — ST. JUDE MEDICAL, INC. · Class III
- Rivacor 3 HF-T QP DF4 IS4 ProMRI — BIOTRONIK SE & Co. KG · Class III
- Unify Assura™ — ST. JUDE MEDICAL, INC. · Class III
- Amplia MRI™ CRT-D SureScan™ — MEDTRONIC, INC. · Class III
- Crome™ HF CRT-D MRI SureScan™ — MEDTRONIC, INC. · Class III
- Unify Quadra™ — ST. JUDE MEDICAL, INC. · Class III
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Scientific
Sources (1)
- FDA UDI e2394d4c-c617-4a1a-891a-78b1375e5e2e 34 fields · synced May 30, 2026