Perclose ProGlide Suture-Mediated Closure System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM FDA PMA
- Generic Name
- Device, hemostasis, vascular FDA PMA
Identifiers
- PMA Number
- P960043 FDA PMA
- FDA Product Code
- MGB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The device is a suture-mediated closure system used for hemostasis and vascular repair. It is indicated for percutaneous delivery of sutures to close the common femoral artery access site and reduce the time to hemostasis and ambulation of patients who have undergone intervention procedures using 8 to 11 French sheaths.
The system is supplied as a Perclose ProStyle Suture-Mediated Closure and Repair System and is regulated as a Class III medical device with FDA PMA authorization. It is intended for single-use and requires proper storage and handling according to manufacturer guidelines.
Frequently asked questions
What is the primary purpose of the Perclose ProGlide and ProStyle systems, and how do they differ in application?
Both systems are designed for suture-mediated closure of the common femoral artery access site after procedures using 8 to 11 French sheaths. The key difference lies in their intended use: the **Perclose ProGlide** is specifically for hemostasis (stopping bleeding), while the **Perclose ProStyle** is for both closure and vascular repair. Both systems reduce time to hemostasis and patient ambulation by delivering sutures percutaneously.
Are the Perclose ProGlide and ProStyle systems reusable, or are they intended for single-use only?
The Perclose ProGlide and ProStyle systems are explicitly intended for **single-use only**. Like most suture-mediated closure devices, they are not designed for reprocessing or reuse to maintain sterility and performance. Proper storage and handling per manufacturer guidelines are required to ensure efficacy.
What sizes of sheaths is this system compatible with, and does it include accessories for use?
The system is compatible with **8 to 11 French sheaths** for common femoral artery access. While the provided data does not list all accessories in detail, the **ProStar PVS System** (a related system) includes a pre-dilator (9 and 11 French), a knot pusher, a transition guidewire, and an arterial tamper—suggesting similar support for proper deployment and closure.
How is the regulatory status of this device determined, and what does the PMA authorization mean for clinicians?
The Perclose ProGlide and ProStyle systems are **Class III medical devices** with **FDA PMA (Premarket Approval) authorization**, meaning they underwent rigorous clinical evaluation to demonstrate safety and effectiveness. This authorization confirms the device meets FDA standards for vascular hemostasis and repair, providing clinicians with confidence in its performance for reducing access-site complications and enabling faster patient recovery.
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 | P960043 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular Inc.
- FDA Applicant
- Abbott Vascular, Inc.
Sources (1)
- FDA PMA P960043 24 fields · synced Sep 18, 2026