Identity
- Trade Name
- BETA-CATH (TM) SYSTEM FDA PMA
- Generic Name
- Intravascular radiation delivery system FDA PMA
Identifiers
- PMA Number
- P000018 FDA PMA
- FDA Product Code
- MOU FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Novoste Beta-Cath System is an Intravascular Radiation Delivery System, designed to deliver beta radiation locally to treat in-stent restenosis in native coronary arteries. It is intended for use following successful percutaneous coronary intervention (PCI) in vessels with a reference diameter between 2.7 mm and 4.0 mm and discrete lesions treatable with a 20 mm balloon.
This system is supplied as a sterile, single-use device and is regulated under FDA PMA approval (PMA Number: P000018). It is intended for use in interventional cardiology settings and requires careful handling per manufacturer instructions. The device is classified as Class III under FDA regulations and is not MRI-compatible.
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 | P000018 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Best Vascular, Inc.
Sources (1)
- FDA PMA P000018 24 fields · synced Sep 18, 2026