Basic Information
- Primary DI
- 18904224914336
- Basic UDI-DI Code
- B-18904224914336
- Reference
- DDL27A
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
Additional Description
An Aortic Pericardial Bioprosthesis is comprised of three leaflets made from bovine pericardial tissue, a frame and a sewing ring. The frame is comprised of a polymer ring (support ring), PET film structures (posts or commissures) and a frame made of Elgiloy* alloy wireform. These three components of frame are covered with polyester fabric. The frame is designed to be compliant at the orifice and commissures. A sewing ring made from polyester fabric is attached to the covered frame. Three contrasting markings are located on this sewing ring. These markings aid in proper orientation for implantation of the prosthesis. A sizer assembly is provided for determining appropriate size of the prosthesis to suit the implant site anatomy.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P070301010101 | STENTED AORTIC BIOLOGICAL VALVES FOR SURGICAL IMPLANT - VALVE TISSUE OF ANIMAL ORIGIN |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-352/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
| MDD Annex II Section 4 | 1434-MDD-351/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).