Controller - India CDSCO Medical Device Registration

Controller is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001147_9bbf373797bf7cf7ba62c80023682e25_e5612aeb7728ba89926d7bf30125e3af. This device is marketed under the brand name HeartWare™ Controller. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Controller

UID: IMP/MD/2023/001147_9bbf373797bf7cf7ba62c80023682e25_e5612aeb7728ba89926d7bf30125e3af

Brand Name

HeartWare™ Controller

License Holder

India Medtronic Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The controller is a microprocessor unit that controls and manages HVAD® System operation. It sends power and operating signals to the blood pump and collects information from the pump. The percutaneous driveline is connected to the controller, which must always be connected to two power sources - an AC adapter or DC adapter and/or rechargeable batteries. The controller’s internal, non-replaceable, rechargeable battery is used to power an audible [No Power] alarm when both power sources are disconnected. The controller interfaces with the monitor through a data port.