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FDA PMA

implantable pacemaker Pulse-generator

PMA Number: P950037 · 2026-10-09

ApplicantBiotronik, Inc.
Decision Date2026-10-09
PMA NumberP950037
Product CodeDXY
Device ClassClass 3
Medical SpecialtyC
Regulation Number21 CFR 8
Advisory CommitteeCV

Device Summary

implantable pacemaker Pulse-generator 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 DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements.

Frequently Asked Questions

What is the implantable pacemaker Pulse-generator?

implantable pacemaker Pulse-generator is a medical device that received FDA 510(k) clearance on 2026-10-09. The listed applicant is Biotronik, Inc..

When did implantable pacemaker Pulse-generator receive FDA 510(k) clearance?

The clearance date for implantable pacemaker Pulse-generator can be found in the official FDA records.

Who is the listed applicant for implantable pacemaker Pulse-generator?

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 implantable pacemaker Pulse-generator?

The FDA product code for implantable pacemaker Pulse-generator is DXY. This falls under the Clinical Chemistry category.

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

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

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