Altaviva System

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Altaviva

Trade Name

Medtronic Altaviva System

Generic Name

Stimulator, tibial, electrical, implantable, for urinary incontinence

PMA Number

P240011 ↗

FDA Product Code

QPT

Device Class

Class III

Advisory Committee

Gastroenterology, Urology

FDA Decision

APPR Approved

• SureTune4 Software

  Class II

  FDA De Novo DEN210003 Active Cleared 23 Aug 2021 FDA 510(k)

• 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

• What is the primary clinical purpose of the Altaviva System, and who is it intended for?

  The Altaviva System is designed as an implantable tibial nerve stimulator to treat **urge urinary incontinence (UUI)** in patients who have not responded to or cannot tolerate conservative treatments like behavioral therapy, medications, or pelvic floor exercises. It delivers targeted electrical pulses to the tibial nerve to help manage incontinence symptoms long-term.

• How is the Altaviva System supplied, and what does this mean for clinical workflows?

  The Altaviva System is **single-patient use only**, meaning each device is intended for one patient and must be implanted under sterile conditions. This ensures patient-specific sterility and reduces cross-contamination risks, requiring proper sterile handling and surgical preparation protocols during implantation.

• Are there specific models or registration numbers I should verify before ordering?

  Yes, the Altaviva System includes multiple authorized models with distinct registration numbers: **3018094310, 3010878085, 3005210579, 3010972758, 3004209178, 3003120897, 2182207, and 3013944123**. Always confirm the exact model and registration number against your inventory or ordering system to ensure compliance with regulatory requirements.

• Does the Altaviva System have any special storage or handling requirements?

  Like all implantable devices, the Altaviva System must be stored and handled according to **standard sterile medical device protocols** to maintain integrity and safety. There are no specific MRI safety restrictions mentioned, but it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use.

• What regulatory pathway does the Altaviva System follow, and what does this mean for purchasing?

  The Altaviva System is approved under **FDA_PMA (P240011)**, a rigorous pathway for Class III devices, which includes implantable neurostimulators. This means it has undergone thorough clinical evaluation and is subject to strict post-market surveillance. Purchasers should ensure they are acquiring the device through authorized channels and verify the **PMA number (P240011)** and registration numbers to confirm authenticity and compliance.