Max. value paid with public resources: Processing

Data for med. device

Medical device code

01AIMDC1084717708

Form date

08/07/2014 15:51

Record date MD

08/07/2014 16:05

Date introduce requestor in the system

09/05/2014 12:46

Identification of the manufacturer

Manufacturer name, long

Thoratec Corporation

Name of the manufacturer, short

Thoratec

Code type

Other

Document type

CE Certificate

Code

CE 563798

Country code

US

City	Pleasanton

Postal code

94588

Street, number

6035 Stoneridge Drive

Contact person

Aarthi Srinivasan

Phone

+925 738 0015

Fax	+925 847 8628

E-mail

Ankita.Tejani@Thoratec.com

Identification of the person placing the product on the market

Name of the person placing the product on the market

MEDILON EOOD

Code type

EIK

Code

121600953

Country code

BG

Region code

SOF

City

Sofia

Postal code

1404

Contact person

Aneta Kostadinova Zhecheva

Phone

02 958 97 87

Fax	02 958 97 67

E-mail

aneta.zhecheva@medilon.bg

Identification of the wholesaler

Wholesaler name

MEDILON EOOD

Code type

EIK

Code

121600953

Country code

BG

Region code

SOF

City

Sofia

Postal code

1404

Contact person

Aneta Kostadinova Zhecheva

Phone

02 958 97 87

Fax	02 958 97 67

E-mail

aneta.zhecheva@medilon.bg

Number of authorization/certificate for wholesale trade with medical devices

ІV - Р - Т/МИ -271

Date of authorization/certificate for wholesale trade with medical devices

21/01/2008

General medical information about the device

Category of the medical device

01 - Active implantable medical devices

Risk clasification

Active implantable medical devices

Anatomical group

Cardiovascular system

Code type

GMDN

Code value

10847

Generic group

Circulatory assist system, ventricular

Name	HeartMate II LVAS Implant Kit

Model

HeartMate II LVAS Implant Kit

Description of the medical device

Characteristics

Sterility

Intended action by the manufacturer

Purpose

Implantable pump system for left ventricular support of the heart. Includes pump, system controller and surgical components. Provided sterile. It is meant for left ventricular circulatory support.

Usage

Single use

Number in catalog

106016

Accessories, consumables

Name Model Reference/catalog number Description Outflow graft Outflow graft 102563 Outflow graft Inflow conduit Inflow conduit 102564 Inflow conduit Apical Coring Knife Apical Coring Knife 1050 Apical Coring Knife Apical Sewing Ring Apical Sewing Ring 1065 Apical Sewing Ring

General trade information

Max. value paid with public resources

Processing

CE certificate number

CE 563798

CE certificate expiration date

04/11/2015