Identity
- Trade Name
- HVAD™ Controller FDA UDI
- Generic Name
- Implantable ventricular circulatory assist system FDA UDI
- Device Name
- CONTROLLER MCS1421CN WW FDA UDI
- Model / Reference
- MCS1421CN FDA UDI
- Description
- CONTROLLER MCS1421CN WW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000989514 FDA UDI
- PMA Number
- P100047 FDA UDI
- FDA Product Code
- DSQ FDA UDI
- GMDN Term
- Implantable ventricular circulatory assist system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Implantable ventricular circulatory assist system
HVAD™ Controller by Heartware Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable ventricular circulatory assist system.
- HeartMate 3™ — Thoratec Corp · Class III
- Surge Cardiovascular — MED MICHIGAN HOLDINGS LLC · Class II
- THORATEC® HEARTMATE II®, PUMP AND CONTROLLER ONLY KIT — Thoratec Corp · Class III
- THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP — Thoratec Corp · Class III
- HeartMate 3™ — Thoratec Corp · Class III
- HeartMate 3™ — Thoratec Corp · Class III
- Thoratec® HeartMate 3™ — Thoratec Corp · Class III
- Thoratec® HeartMate 3™ — Thoratec Corp · Class III
Cleared under the same submission
P100047 also covers:
- Alarm Adapter — Heartware Inc.
- Data Cable — Heartware Inc.
- Explant Kit — Heartware Inc.
- HVAD® Controller — Heartware Inc.
- HVAD® Pump Surgical Tools — Heartware Inc.
- HVAD® Pump Surgical Tools — Heartware Inc.
- HVAD® Pump Surgical Tools – Extended Length — Heartware Inc.
- HVAD® Pump Surgical Tools – Extended Length — Heartware Inc.
- HeartWare® Battery — Heartware Inc.
- HeartWare® Controller AC Adapter — Heartware Inc.
- HeartWare® Controller DC Adapter — Heartware Inc.
- HeartWare® Monitor — Heartware Inc.
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
- Heartware Inc.
Sources (1)
- FDA UDI 00f163be-e96e-4f5e-921b-e62bb8d532c2 36 fields · synced May 31, 2026