Identity
- Trade Name
- ANGIOSCULPT SCORING BALLOON CATHETER FDA PMA
- Generic Name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring FDA PMA
Identifiers
- PMA Number
- P050018 FDA PMA
- FDA Product Code
- NWX FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Angiosculpt Scoring Balloon Catheter is a percutaneous transluminal coronary angioplasty (PTCA) device with a cutting/scoring mechanism. It is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex Type C lesions, to improve myocardial perfusion.
Supplied by Spectranetics Corp., this device is authorized under FDA PMA P050018. It is intended for use in coronary interventions and is classified as a Class III medical device.
Frequently asked questions
What is the Angiosculpt Scoring Balloon Catheter used for?
The Angiosculpt Scoring Balloon Catheter is indicated for the treatment of hemodynamically significant coronary artery stenosis, including in-stent restenosis and complex Type C lesions, with the purpose of improving myocardial perfusion.
Who manufactures the Angiosculpt Scoring Balloon Catheter?
The Angiosculpt Scoring Balloon Catheter is manufactured by Spectranetics Corp., located in Fremont, California.
What regulatory authorization does the Angiosculpt Scoring Balloon Catheter have?
The device has received FDA PMA approval, as indicated by the PMA number P050018 and the decision code APPR from January 8, 2007.
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 | P050018 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spectranetics Corp.
Sources (1)
- FDA PMA P050018 24 fields · synced Sep 18, 2026