Identity
- Trade Name
- HeartMate II®, System Controller FDA UDI
- Generic Name
- Implantable ventricular circulatory assist system control unit FDA UDI
- Model / Reference
- 105472 FDA UDI
Identifiers
- Catalog Number
- 105472 FDA UDI
- Primary DI / UDI-DI
- 00813024012542 FDA UDI
- PMA Number
- P060040 FDA UDI
- FDA Product Code
- DSQ FDA UDI
- GMDN Term
- Implantable ventricular circulatory assist system control unit 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Implantable ventricular circulatory assist system control unit
HeartMate II®, System Controller by Thoratec Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable ventricular circulatory assist system control unit.
- TLC-II® SYSTEM DRIVER — Thoratec Corp · Class III
- HeartMate II®, System Controller — Thoratec Corp · Class III
- TLC- II SYSTEM DRIVER — Thoratec Corp · Class III
- Thoratec® HeartMate 3™ — Thoratec Corp · Class III
- HeartMate 3™ — Thoratec Corp · Class III
- THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP — Thoratec Corp · Class III
- VAD DRIVER DOMESTIC — Thoratec Corp · Class III
- THORATEC® HEARTMATE II®, SYSTEM CONTROLLER — Thoratec Corp · Class III
Cleared under the same submission
P060040 also covers:
- HeartMate Touch™ — Thoratec Corp
- HeartMate Touch™ — Thoratec Corp
- HeartMate Touch™ — Thoratec Corp
- HeartMate™ — Thoratec Corp
- HeartMate™ — Thoratec Corp
- HeartMate™ — Thoratec Corp
- HeartMate™ — Thoratec Corp
- HeartMate™ — Thoratec Corp
- HeartMate™ — Thoratec Corp
- HeartMate™ GoGear™ — Thoratec Corp
- Thoratec® HeartMate® ICU Cover (6 Pack) — Thoratec Corp
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
- Thoratec Corp
Sources (1)
- FDA UDI 02778013-e481-4ab2-b75c-100a34681b37 36 fields · synced May 30, 2026