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FDA PMA

Stimulator, electrical, implantable, for incontinence

PMA Number: P180046 · 2026-08-07

ApplicantBoston Scientific Corporation
Decision Date2026-08-07
PMA NumberP180046
Product CodeEZW
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeGU

Device Summary

Stimulator, electrical, implantable, for incontinence is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-08-07. The device is classified under product code EZW. It was reviewed by the GU advisory panel.

Frequently Asked Questions

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

Stimulator, electrical, implantable, for incontinence is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Boston Scientific Corporation.

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

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

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

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

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

The FDA product code for Stimulator, electrical, implantable, for incontinence is EZW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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