Spanner Temporary Prostatic Stent
by Srs Medical
PMA P060010
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP060010 | Date14 Dec 2006 | 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- Withdrawn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
- The Spanner Temporary Prostatic Stent
- Generic Name
- Stent, urethral, prostatic, semi-permanent
- PMA Number
- FDA Product Code
- NZC
- Device Class
- Class III
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Spanner Temporary Prostatic Stent is a semi-permanent urethral stent designed to maintain urine flow and facilitate voluntary urination in patients. It is intended for temporary use (up to 30 days) following minimally invasive treatment for benign prostatic hyperplasia (BPH) and after initial post-treatment catheterization.
This device is supplied sterile and intended for single-use. It is classified as a Class III medical device under FDA regulations and requires a Premarket Approval (PMA) application. The Spanner Temporary Prostatic Stent is regulated under PMA number P060010 and falls under the product code NZC for urethral stents.
Other devices from Srs Medical
Questions
AI-generated answers, 18 Sep 2026
What is the Spanner Temporary Prostatic Stent primarily used for in clinical practice?
The Spanner Temporary Prostatic Stent is designed to maintain urine flow and enable voluntary urination in patients temporarily, specifically after minimally invasive treatments for benign prostatic hyperplasia (BPH) or following initial post-treatment catheterization. It is intended for short-term use (up to 30 days) to support recovery and reduce reliance on catheters during this period.
Is the Spanner Temporary Prostatic Stent meant for long-term use, or is it strictly temporary?
The Spanner Temporary Prostatic Stent is explicitly intended for temporary use only, with a maximum duration of 30 days. Its design and regulatory approval reflect this limited-time application, ensuring it supports recovery without prolonged implantation.
How is the Spanner Temporary Prostatic Stent supplied, and is it reusable?
The Spanner Temporary Prostatic Stent is supplied sterile and is intended for single-use only. This ensures patient safety and hygiene, as reuse could introduce infection risks or compromise device integrity.
What regulatory pathway does the Spanner Temporary Prostatic Stent follow, and how does that affect its availability?
The Spanner Temporary Prostatic Stent requires Premarket Approval (PMA) under FDA regulations, with approval granted via PMA number P060010. This classification (Class III) means it undergoes rigorous review by the FDA’s Gastroenterology and Urology advisory committee before being authorized for use, ensuring its safety and effectiveness for the specified temporary application.