Orsiro Sirolimus Eluting Coronary Stent System
FDA PMAClass III (US FDA PMA)
by Biotronik AG
Identity
- Trade Name
- ORSIRO Sirolimus Eluting Coronary Stent System FDA PMA
- Generic Name
- Coronary drug-eluting stent FDA PMA
Identifiers
- PMA Number
- P170030 FDA PMA
- FDA Product Code
- NIQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Orsiro Sirolimus Eluting Coronary Stent System is a coronary drug-eluting stent indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to atherosclerotic lesions in native coronary arteries. It is designed for use in lesions with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of less than 36 mm.
The device is supplied sterile and intended for single-use during percutaneous coronary intervention procedures. It has received FDA PMA approval (P170030) and is manufactured by Biotronik AG in Bülach, Switzerland.
Frequently asked questions
What is the Orsiro Sirolimus Eluting Coronary Stent System indicated for?
The Orsiro Sirolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of less than 36 mm.
Who manufactures the Orsiro Sirolimus Eluting Coronary Stent System and where is it made?
The Orsiro Sirolimus Eluting Coronary Stent System is manufactured by Biotronik AG, with the applicant and manufacturer located at Ackerstrasse 6, Bülach, 8180, Switzerland.
What regulatory authorization does the Orsiro Sirolimus Eluting Coronary Stent System have?
The Orsiro Sirolimus Eluting Coronary Stent System has received FDA PMA approval, as indicated by the PMA number P170030 and the decision code APPR with a decision date of 2019-02-22.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P170030 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik AG
Sources (1)
- FDA PMA P170030 24 fields · synced Sep 18, 2026