Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA PMA

Implanted fecal incontinence device

PMA Number: P010020 · 2016-02-04

ApplicantBoston Scientific Corp
Decision Date2016-02-04
PMA NumberP010020
Product CodeMIP
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

Implanted fecal incontinence device is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2016-02-04. The device is classified under product code MIP. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the Implanted fecal incontinence device?

Implanted fecal incontinence device is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Boston Scientific Corp.

When did Implanted fecal incontinence device receive FDA 510(k) clearance?

The clearance date for Implanted fecal incontinence device can be found in the official FDA records.

Who is the listed applicant for Implanted fecal incontinence device?

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

What is the FDA product code for Implanted fecal incontinence device?

The FDA product code for Implanted fecal incontinence device is MIP.

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.

↑