Pacing Lead - India CDSCO Medical Device Registration
Pacing Lead is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000222_7ced2c3ea8dce3d130cf57913ed1ed17_9ca79f7a45636fb120d710cfa3839817. This device is marketed under the brand name Optisure. 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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Brand Name
Optisure
License Holder
M/s St. Jude Medical India Pvt. LtdDevice Class
Approving Authority
CDSCO
Product Information
IsoFlex leads are designed for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium or ventricle. IsoFlex model 1948 is intended to be placed in either the right atrium or the right ventricle
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