Max. value paid with public resources: Processing

Data for med. device

Medical device code

07IIIC1718419572

Form date

14/12/2016 10:42

Record date MD

14/12/2016 14:47

Date introduce requestor in the system

02/12/2016 17:16

Identification of the manufacturer

Manufacturer name, long

Lutonix, Inc.

Code type

Other

Document type

US

Code

US

Country code

US

City

New Hope

Postal code

MN 55428

Contact person

Isabel De La Cal Garcia

Phone

+49 721 9445 463

E-mail

Isabel.DeLaCal@crbard.com

Identification of the person placing the product on the market

Name of the person placing the product on the market

Devimed Ltd.

Code type

EIK

Code

130322047

Country code

BG

Region code

SOF

City

Sofia

Contact person

Aleksandar Madzharov

Phone

029533616

E-mail

devimed@abv.bg

Identification of the wholesaler

Wholesaler name

Devimed Ltd.

Code type

EIK

Code

130322047

Country code

BG

Region code

SOF

City

Sofia

Contact person

Aleksandar Madzharov

Phone

029533616

E-mail

devimed@abv.bg

Number of authorization/certificate for wholesale trade with medical devices

IV-Р-Т/МИ-180

Date of authorization/certificate for wholesale trade with medical devices

10/12/2007

General medical information about the device

Category of the medical device

07 - Non-active implantable devices

Risk clasification

Class ІІІ

Anatomical group

Cardiovascular system

Code type

GMDN

Code value

17184

Generic group

Catheter, angioplasty, balloon dilatation

Name	Lutonix 035 Drug Coated Balloon PTA Catheter

Description of the medical device

Characteristics

Sterility, Hospital prescription

Intended action by the manufacturer

Purpose

The Lutonix® 035 Drug Coated Balloon PTA Catheter (Lutonix® Catheter) consists of an over the wire catheter with a drug coated balloon fixed at the distal tip. The Lutonix® 035 Drug Coated Balloon Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature and for the treatment of obstructive lesions and decreasing the incidence of restenosis. In addition, the Lutonix® 035 Drug Coated Balloon Catheter is intended for PTA of native dialysis fistulae or synthetic grafts, opening narrowing and immature fistulae, to improve blood flow, and decreasing the incidence of restenosis

Usage

Single use

General trade information

Max. value paid with public resources

Processing

CE certificate number

1434-MDD-50/2016

CE certificate expiration date

19/07/2019