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Smart Control and Smart Vascular Stent Systems

by Cordis US Corporation

PMA P120002

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P120002↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP120002 Date7 Nov 2012ApprovedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
Smart Control Vascular Stent Systems
Trade Name
Sma Rt Control and Smart Vascular Stent Systems
Generic Name
STENT, SUPERFICIAL FEMORAL ARTERY
PMA Number
FDA Product Code
NIP
Device Class
Class III
Advisory Committee
Cardiovascular
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Smart Control and Smart Vascular Stent Systems are superficial femoral artery stents designed to improve luminal diameter. They are indicated for the treatment of patients with de novo or restenotic native lesions of the superficial femoral artery and proximal popliteal artery.

These systems are suitable for lesions with a total length of up to 150 mm and reference vessel diameters ranging from 4 mm to 7 mm. The device has received FDA PMA authorization for clinical use in the specified cardiovascular applications.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Smart Control and Smart Vascular Stent Systems?

    These systems are intended to improve luminal diameter in patients suffering from de novo or restenotic native lesions within the superficial femoral artery and proximal popliteal artery.

  • What vessel dimensions are compatible with these stents?

    The stents are indicated for use in vessels with a reference diameter between 4 mm and 7 mm and for lesions measuring up to 150 mm in total length.

  • Has this device received regulatory authorization?

    Yes, the Smart Control and Smart Vascular Stent Systems have received FDA PMA approval for their indicated use in cardiovascular procedures.