SureTune4 Software

No FDA recalls found in the data synced 10 Oct 2026.

De Novo Number

DEN210003 ↗

FDA Product Code

QQC

Device Class

Class II

Regulation

21 CFR Part 882.5855

Advisory Committee

Neurology

FDA Decision

DENG De Novo granted

• Altaviva System

  Class III

  FDA PMA P240011 Active Approved 18 Sep 2025

• InterStim Therapy System, Verify Evaluation System Open recall

  Class III

  FDA PMA P080025 Active Approved 14 Mar 2011

• Interstim Therapy System for Urinary Control Open recall

  Class III

  FDA PMA P970004 Active Approved 29 Sep 1997

• Itrel, Synergy and Intellis Spnal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lead Open recall

  Class III

  FDA PMA P840001 Active Approved 30 Nov 1984