Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
MEDTRONIC INTERNATIONAL, LTD.
Class D medical device
Medtronic Inc.
Cardiovascular
It is indicated for the replacement of pathologic or prosthetic aortic valves. The full root model (FR995) is also indicated for pulmonary valve replacement, and right ventricular outflow tract (RVOT) reconstruction.
Device System Info:[Sterile Medical Device], Device has been sterilized using liquid chemical sterilants according to EN/ISO 14160/Sterile LC.; Models: FreeStyle® Bioprosthesis - FR995-19, FreeStyle® Bioprosthesis - FR995-21, FreeStyle® Bioprosthesis - FR995-23, FreeStyle® Bioprosthesis - FR995-25, FreeStyle® Bioprosthesis - FR995-27, FreeStyle® Bioprosthesis - FR995-29, FreeStyle® Bioprosthesis - 995CS19, FreeStyle® Bioprosthesis - 995CS21, FreeStyle® Bioprosthesis - 995CS23, FreeStyle® Bioprosthesis - 995CS25, FreeStyle® Bioprosthesis - 995CS27, FreeStyle® Bioprosthesis - 995CS29, FreeStyle® Bioprosthesis - 995MS19, FreeStyle® Bioprosthesis - 995MS21, FreeStyle® Bioprosthesis - 995MS23, FreeStyle® Bioprosthesis - 995MS25, FreeStyle® Bioprosthesis - 995MS27, FreeStyle® Bioprosthesis - 995MS29, FreeStyle® Bioprosthesis - 7990, FreeStyle® Bioprosthesis - 0791, FreeStyle® Bioprosthesis - 7639
2005-09-15