FDA PMA

Stimulator, tibial, electrical, implantable, for urinary incontinence

Numéro PMA : P240011 · 2026-09-14

DemandeurMedtronic Neuromodulation

Date de décision2026-09-14

Numéro PMAP240011

Code produitQPT

Classe de dispositifClasse 3

Spécialité médicaleU

Comité consultatifGU

Résumé du dispositif

Stimulator, tibial, electrical, implantable, for urinary incontinence is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neuromodulation. It received FDA 510(k) clearance on 2026-09-14. The device is classified under product code QPT. It was reviewed by the GU advisory panel.

Questions fréquentes

What is the Stimulator, tibial, electrical, implantable, for urinary incontinence?

Stimulator, tibial, electrical, implantable, for urinary incontinence is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Medtronic Neuromodulation.

When did Stimulator, tibial, electrical, implantable, for urinary incontinence receive FDA 510(k) clearance?

The clearance date for Stimulator, tibial, electrical, implantable, for urinary incontinence can be found in the official FDA records.

Who is the listed applicant for Stimulator, tibial, electrical, implantable, for urinary incontinence?

The FDA 510(k) record lists Medtronic Neuromodulation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stimulator, tibial, electrical, implantable, for urinary incontinence?

The FDA product code for Stimulator, tibial, electrical, implantable, for urinary incontinence is QPT.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.