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FDA PMA

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

PMA Number: P000009 · 2026-10-09

ApplicantBiotronik, Inc.
Decision Date2026-10-09
PMA NumberP000009
Product CodeMRM
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2026-10-09. The device is classified under product code MRM. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER?

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER is a medical device that received FDA 510(k) clearance on 2026-10-09. The listed applicant is Biotronik, Inc..

When did DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER receive FDA 510(k) clearance?

The clearance date for DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER can be found in the official FDA records.

Who is the listed applicant for DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER?

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

What is the FDA product code for DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER?

The FDA product code for DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER is MRM.

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.

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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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