Combo Plus
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Basic Information
- Primary DI
- 08717853297342
- Basic UDI-DI Code
- B-08717853297342
- Reference
- 225-232-11
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- OrbusNeich Medical, B.V.
Additional Description
The COMBO Plus Stent is a coronary balloon expandable vascular prosthesis. The COMBO Plus Stent consists of a 316L stainless steel alloy coated with a biocompatible, biodegradable polymer containing sirolimus (also known as rapamycin). Covalently attached to this matrix is a layer of murine, monoclonal, anti-human CD34 antibody. The antibody specifically targets CD34+ cells in circulation. Endothelial progenitor cells (EPCs) are CD34+. This stent is supplied premounted on a delivery catheter.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P070402010301 | CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | CE 649589 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).