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FDA PMA

Pulse-generator, single chamber, sensor driven, implantable

PMA Number: P850051 · 2025-03-20

ApplicantMedtronic, Inc.
Decision Date2025-03-20
PMA NumberP850051
Product CodeLWO
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Pulse-generator, single chamber, sensor driven, implantable is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2025-03-20. The device is classified under product code LWO. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Pulse-generator, single chamber, sensor driven, implantable?

Pulse-generator, single chamber, sensor driven, implantable is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Medtronic, Inc..

When did Pulse-generator, single chamber, sensor driven, implantable receive FDA 510(k) clearance?

The clearance date for Pulse-generator, single chamber, sensor driven, implantable can be found in the official FDA records.

Who is the listed applicant for Pulse-generator, single chamber, sensor driven, implantable?

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

What is the FDA product code for Pulse-generator, single chamber, sensor driven, implantable?

The FDA product code for Pulse-generator, single chamber, sensor driven, implantable is LWO.

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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