PAS Champion Catheter 30 mm Long Balloons
by Progressive Angioplasty Systems, Inc.
PMA P930012
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP930012 | Date18 Nov 1996 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Pas Champion(Tm) Catheter 30 Mm Long Balloons
- Generic Name
- Catheters, transluminal coronary angioplasty, percutaneous
- PMA Number
- FDA Product Code
- LOX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5100
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
- PMA Supplement
- S004 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
The PAS Champion Catheter is a Catheter, Transluminal Coronary Angioplasty, Percutaneous, designed for percutaneous transluminal coronary angioplasty (PTCA). It features a 30 mm long balloon intended to dilate narrowed or obstructed coronary arteries, improving blood flow to the heart muscle. The device is part of a catheter line with multiple balloon sizes, including 2.5 mm, 3.0 mm, and 3.5 mm in addition to the 30 mm length.
This catheter is supplied as a single-use, non-sterile device and is intended for use in controlled clinical settings such as cardiac catheterization labs. It is classified under FDA regulation number 870.5100 and holds a PMA approval (P930012). The device is not MRI-safe, and proper handling, storage, and disposal must comply with medical device regulations and institutional protocols. Sizes and specifications are standardized for compatibility with coronary intervention procedures.
Questions
AI-generated answers, 18 Sep 2026
What is the primary use of the PAS Champion Catheter with 30 mm long balloons in a clinical setting?
The PAS Champion Catheter with 30 mm long balloons is specifically designed for percutaneous transluminal coronary angioplasty (PTCA), a procedure used to dilate narrowed or obstructed coronary arteries. This improves blood flow to the heart muscle by expanding the narrowed segments, restoring proper vessel diameter for optimal cardiac function.
Is the PAS Champion Catheter single-use or reusable, and how should it be handled?
The PAS Champion Catheter is intended for single-use only and is supplied in a non-sterile state. It must be used in controlled clinical settings like cardiac catheterization labs, where proper handling, storage, and disposal comply with medical device regulations and institutional protocols to ensure patient safety and infection control.
What balloon sizes are available in the PAS Champion Catheter line, and how does the 30 mm length compare?
The PAS Champion Catheter line includes multiple balloon sizes, with the 30 mm length available in 2.5 mm, 3.0 mm, and 3.5 mm diameters. This 30 mm length is designed for longer coronary lesions, allowing for targeted dilation of extended segments within the coronary arteries while maintaining compatibility with standard PTCA procedures.
How should the PAS Champion Catheter be stored, and are there any special considerations for its use?
While specific storage instructions are not detailed in the provided data, the device is non-sterile and intended for single-use in controlled clinical settings, such as cardiac catheterization labs. Proper storage should follow manufacturer guidelines to maintain integrity until use, and institutional protocols must be followed for handling, disposal, and compliance with medical device regulations. Additionally, the catheter is not MRI-safe, so caution must be exercised in environments where MRI equipment is present.