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Basic Information
- Primary DI
- 18904224927275
- Basic UDI-DI Code
- B-18904224927275
- Reference
- PRV20037
- 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
The Prevade™ Sirolimus Eluting Stent System comprises of following components -A balloon-expandable L605 Cobalt Chromium Coronary Stent -A stent coating that consists of a blend of anti-proliferative drug and polymers 1. Anti-proliferative drug Sirolimus (also known as Rapamycin) 2. Bio-compatible, bio-degradable co-polymer coating which acts as drug reservoir and drug release platform -A rapid-exchange stent delivery PTCA balloon catheter -The stent is pre mounted on balloon catheter & placed between two platinum-iridium radio opaque markers bands.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P070402010301 | CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 1434-MDD-331/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
| MDD Annex II (excluding section 4) | 1434-MDD-332/2021 | 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).