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Basic Information
- Primary DI
- 18904224915289
- Basic UDI-DI Code
- B-18904224915289
- Reference
- MRS40019
- 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 Sirolimus Eluting Bioresorbable Vascular Scaffold System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesion in native coronary arteries in patients eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) and Scaffolding procedures. The scaffold will eventually resorb and potentially facilitate normalization of vessel function in patients. Covering of minimum 2 mm of non-diseased tissue on either side of the target lesion is recommended. For example, the lesion length may not be more than 15 mm for the scaffold with 19 mm length.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P0704020104 | CORONARY STENTS, ABSORBABLE |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 1783- MDD-119 | TURKISH STANDARDS INSTITUTION (TSE) | Expired |
| MDD Annex II (excluding section 4) | 1783- MDD-118 | TURKISH STANDARDS INSTITUTION (TSE) | Expired |
Available In Countries
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