CDSCO UID IMP/MD/2019/000539_a5401db954f3f81262cc02b03b853190_81b8612dc5a94c2e6eb27fe46601b0db
Annuloplasty Ring
M/s St. Jude Medical India Pvt. Ltd·Device Class Class C·India CDSCO·Brand: SJM Tailor Annuloplasty Ring
Registration details
- UID
- IMP/MD/2019/000539_a5401db954f3f81262cc02b03b853190_81b8612dc5a94c2e6eb27fe46601b0db
- Device class
- Class C
- Brand name
- SJM Tailor Annuloplasty Ring
- License holder
- M/s St. Jude Medical India Pvt. Ltd
- 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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About this record
Annuloplasty Ring is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000539_a5401db954f3f81262cc02b03b853190_81b8612dc5a94c2e6eb27fe46601b0db. This device is marketed under the brand name SJM Tailor 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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