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FDA PMA

permanent pacemaker Electrode

PMA Number: P130012 · 2024-04-19

ApplicantGreat Batch Medical
Decision Date2024-04-19
PMA NumberP130012
Product CodeDTB
Device ClassClass 3
Medical SpecialtyC
Regulation Number21 CFR 8
Advisory CommitteeCV

Device Summary

permanent pacemaker Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Great Batch Medical. It received FDA 510(k) clearance on 2024-04-19. The device is classified under product code DTB. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the permanent pacemaker Electrode?

permanent pacemaker Electrode is a medical device that received FDA 510(k) clearance on 2024-04-19. The listed applicant is Great Batch Medical.

When did permanent pacemaker Electrode receive FDA 510(k) clearance?

The clearance date for permanent pacemaker Electrode can be found in the official FDA records.

Who is the listed applicant for permanent pacemaker Electrode?

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

What is the FDA product code for permanent pacemaker Electrode?

The FDA product code for permanent pacemaker Electrode is DTB.

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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