Identity
- Trade Name
- RITHRON-XR CORONARY STENT SYSTEM FDA PMA
- Generic Name
- STENT, CORONARY FDA PMA
Identifiers
- PMA Number
- P030037 FDA PMA
- FDA Product Code
- MAF FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Rithron-Xr Coronary Stent System is a coronary stent indicated for use in patients eligible for balloon angioplasty with symptomatic ischemic heart disease characterized by discrete de novo coronary artery lesions. It is designed for reference vessel diameters from >=3.0 mm or <=4.0 mm and target lesion lengths <=20.0 mm.
Supplied by Biotronik GmbH & Co. KG, the device is authorized under FDA PMA P030037 and classified as a Class III coronary stent. It is intended for use in cardiovascular procedures as specified in the approval documentation.
Frequently asked questions
What is the Rithron-Xr Coronary Stent System indicated for?
The Rithron-Xr Coronary Stent System is indicated for use in patients eligible for balloon angioplasty with symptomatic ischemic heart disease characterized by discrete de novo coronary artery lesions with reference vessel diameter from >=3.0 mm or <=4.0 mm and target lesion length <=20.0 mm, as stated in the approval documentation.
Who manufactures the Rithron-Xr Coronary Stent System?
The Rithron-Xr Coronary Stent System is manufactured by Biotronik GmbH & Co. KG, as specified in the applicant and manufacturer fields of the device data.
What regulatory authorization does the Rithron-Xr Coronary Stent System have?
The Rithron-Xr Coronary Stent System has FDA PMA authorization, with PMA number P030037, as indicated in the AUTHORIZATIONS and pma_number fields.
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 | P030037 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik GmbH & Co. KG
Sources (1)
- FDA PMA P030037 24 fields · synced Sep 18, 2026