Programmer - India CDSCO Medical Device Registration

Programmer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000825_987c70ecbcd643998ea6bcd3b8868934_7b48edf0cdb74e5bd8c769a89fadcaae. This device is marketed under the brand name Merlin PCS 3650 Software. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Programmer

UID: IMP/MD/2023/000825_987c70ecbcd643998ea6bcd3b8868934_7b48edf0cdb74e5bd8c769a89fadcaae

Brand Name

Merlin PCS 3650 Software

License Holder

M/s St. Jude Medical India Pvt. Ltd

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Merlin 2 PCS (Merlin PCS 3650 Software) is a portable, dedicated programming system designed to interrogate, program, display data from, and test St. Jude Medical implantable medical devices during implant and follow up. The Telemetry Wand Model 3630W is intended to provide inductive communication between the programmer and the implantable medical device during a programmer session. The Merlin 2 PCS ECG function when using the ECG cable Models 3617, 3626, and EX3001 is only intended to support activities related to implanting, programming, and monitoring St. Jude Medical implantable medical devices. The Merlin Antenna Model 3638 is a dedicated radio antenna accessory intended to enable wireless radio frequency (Merlin PCS 3650 Software) communication between the Merlin 2 PCS and St. Jude Medical implantable medical devices with RF communication capability during a programmer session. The Merlin PSA Model EX3100 is a pacing analyzer system intended for use with the Merlin 2 PCS to evaluate St. Jude Medical implanted leads for integrity, and for pacing and sensing performance during surgical procedures related to the implanted system