Supera Peripheral Stent System

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

STENT, SUPERFICIAL FEMORAL ARTERY

PMA Number

P120020 ↗

FDA Product Code

NIP

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

• What arteries is the Supera Peripheral Stent System designed to treat, and what are the key vessel size and lesion length requirements?

  The Supera Peripheral Stent System is specifically designed for the superficial femoral artery (SFA) and proximal popliteal artery. It is intended for patients with symptomatic de novo or restenotic native lesions or occlusions, with reference vessel diameters ranging from 4.0 to 6.5 mm and lesion lengths up to 140 mm. These specifications ensure compatibility with the anatomical and pathological characteristics of these arteries.

• Is the Supera Peripheral Stent System intended for reuse, or is it meant to be used only once?

  The Supera Peripheral Stent System is supplied sterile and explicitly intended for **single-use only**. This aligns with standard practices for Class III medical devices to ensure patient safety and sterility integrity, as outlined in its regulatory documentation.

• What storage and handling precautions should be taken with the Supera Peripheral Stent System?

  The Supera Peripheral Stent System must be stored and handled in accordance with standard sterile procedures for Class III devices. While specific storage conditions (e.g., temperature, humidity) aren’t detailed here, compliance with regulatory requirements for sterility and integrity is mandatory. Avoid exposure to moisture, contamination, or physical damage, as these could compromise its performance or sterility.

• Can the Supera Peripheral Stent System be used in patients who require MRI scans, or does it have MRI-related restrictions?

  The Supera Peripheral Stent System is **not indicated for MRI use**. This restriction is explicitly stated in its documentation, meaning patients implanted with this device should avoid MRI procedures to prevent potential risks like heating or imaging artifacts.

• How is the regulatory approval process for the Supera Peripheral Stent System categorized, and what does this mean for its use?

  The Supera Peripheral Stent System holds an **FDA Premarket Approval (PMA)** under product code **NIP**, confirming it meets stringent Class III requirements. This approval route ensures rigorous evaluation of safety and effectiveness before clinical use, providing confidence in its performance for treating SFA and proximal popliteal artery lesions as specified.