Wallstent Venous Endoprosthesis with Unistep Plus Delivery System
PMA P980033
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP980033 | Date16 Nov 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Wallstent Endoprosthesis
- Generic Name
- Stent, central venous
- FDA applicant
- Boston Scientific Corporation
- PMA Number
- FDA Product Code
- QKJ
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Wallstent Venous Endoprosthesis with Unistep Plus Delivery System is a Stent, Central Venous (per OpenFDA nomenclature), designed to improve central venous luminal diameter in patients with venous outflow tract stenosis. It is intended for use following unsuccessful angioplasty in chronic hemodialysis patients, addressing residual stenosis, vessel tears, abrupt occlusion, or refractory spasm in veins ranging from 8 mm to 15 mm in diameter, including the innominate and subclavian veins. The device is deployed via the Unistep Plus delivery system, ensuring precise placement within specified vessel sizes (10 mm, 12 mm, and 16 mm).
This device is supplied sterile and intended for single-use, requiring interventional radiology or cardiology settings for deployment. It is classified as a Class III medical device under FDA regulations and has received FDA_PMA approval (PMA Number: P980033). Storage conditions are not specified but must adhere to standard sterile device protocols. The Wallstent system is regulated under the QKJ product code and is tracked via OpenFDA registration numbers.
Other devices from Boston Scientific
Questions
AI-generated answers, 18 Sep 2026
What specific venous conditions does the Wallstent Venous Endoprosthesis address after angioplasty failure in hemodialysis patients?
The Wallstent Venous Endoprosthesis is designed to treat residual stenosis, vessel tears (where the vein’s lining or lumen is disrupted), abrupt occlusion, or refractory spasm in central veins following unsuccessful angioplasty. It targets veins like the innominate and subclavian, with diameters between 8 mm and 15 mm, where angioplasty left behind significant narrowing (≥30% for veins ≤10 mm or ≥50% for veins >10 mm) or other complications.
What sizes of the Wallstent Venous Endoprosthesis are available, and how do they match the vessel diameter?
The Wallstent Venous Endoprosthesis comes in three sizes: 10 mm, 12 mm, and 16 mm. These correspond to the deployed diameter of the stent, which is intended for veins ranging from 8 mm to 15 mm in diameter, ensuring compatibility with the innominate and subclavian veins as specified in the design.
Is the Wallstent Venous Endoprosthesis with Unistep Plus Delivery System meant for reuse, or is it single-use?
The Wallstent Venous Endoprosthesis with Unistep Plus Delivery System is explicitly intended for **single-use only**. This aligns with standard sterile medical device protocols, requiring deployment in controlled settings like interventional radiology or cardiology suites.
What storage conditions should be followed for the Wallstent Venous Endoprosthesis?
While specific storage conditions aren’t detailed in the data, as a sterile medical device, it must be handled according to **standard sterile device protocols** to maintain integrity until use. This typically includes protection from contamination, extreme temperatures, and physical damage.
How is the Wallstent Venous Endoprosthesis deployed, and what role does the Unistep Plus Delivery System play?
The Wallstent Venous Endoprosthesis is deployed via the **Unistep Plus Delivery System**, which ensures precise placement within the specified vessel sizes (10 mm, 12 mm, and 16 mm). The system is designed to facilitate accurate stent expansion and positioning in central veins like the innominate and subclavian, addressing residual stenosis or other complications after failed angioplasty.