Identification of the person placing the product on the market
Marimpex-7 Ltd
EIK
130489377
BG
SOF
Sofia
1612
bul.Tzar Boris III N 54
Adriana Bozhkova
02 9532561
02 9595821
office@marimpex7.bg
Identification of the wholesaler
Marimpex-7 Ltd
EIK
130489377
BG
SOF
Sofia
1612
bul.Tzar Boris III N 54
Adriana Bozhkova
02 9532561
02 9595821
office@marimpex7.bg
IV-Р-Т/МИ-186
11/12/2007
General medical information about the device
07 - Non-active implantable devices
Class ІІІ
Cardiovascular system
GMDN
60245
Aortic Bioprosthesis
ACURATE neo™ AORTIC BIOPROSTHESIS
Description of the medical device
1
Sterility, Hospital prescription
Intended action by the manufacturer
The ACURATE neo™ Aortic Bioprosthesis and its Delivery System are indicated for use in patients 75 years of age and older with severe aortic stenosis. for whom conventional surgical aortic valve replacement is considered high risk for mortality or who are not operable