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Annuloplasty Ring - India CDSCO Medical Device Registration

Annuloplasty Ring is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000020_a5401db954f3f81262cc02b03b853190_96116a1da61c445f056d5bdf8c6e0707. This device is marketed under the brand name SJM Rigid Saddle Annuloplasty Ring. The license holder is M/s St. Jude Medical India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Annuloplasty Ring
UID: IMP/MD/2020/000020_a5401db954f3f81262cc02b03b853190_96116a1da61c445f056d5bdf8c6e0707

Brand Name

SJM Rigid Saddle Annuloplasty Ring

Device Class

Class C

Approving Authority

CDSCO

Product Information

It is indicated for use to correct annular dilation, increase leaflet coaptation, and prevent further dilation of the mitral valve annulus caused by disease states such as degenerative disease, rheumatic disease, ischemia, or vascular disease. The combination of prosthetic ring with valvuloplasty may be used in all acquired or congenital mitral insufficiencies with dilation and deformation of the fibrous mitral annulus. For mitral insufficiencies with no sub valvular lesions and normal valvular movements, prosthetic ring implant alone may be sufficient. However, annuloplasty ring implant along with mitral valvuloplasty repair must be considered for insufficiencies with a prolapsed valve due to elongation or rupture of the chordae tendineae and for insufficiencies with limitation of valvular movements due to fusion of the commissures or chordae tendineae, or chordal hypertrophy

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