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FDA PMA

Implantable pulse generator, pacemaker (non-CRT)

PMA Number: N970003 · 2026-10-03

ApplicantBoston Scientific Corp
Decision Date2026-10-03
PMA NumberN970003
Product CodeLWP
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Implantable pulse generator, pacemaker (non-CRT) 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 2026-10-03. The device is classified under product code LWP. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Implantable pulse generator, pacemaker (non-CRT)?

Implantable pulse generator, pacemaker (non-CRT) is a medical device that received FDA 510(k) clearance on 2026-10-03. The listed applicant is Boston Scientific Corp.

When did Implantable pulse generator, pacemaker (non-CRT) receive FDA 510(k) clearance?

The clearance date for Implantable pulse generator, pacemaker (non-CRT) can be found in the official FDA records.

Who is the listed applicant for Implantable pulse generator, pacemaker (non-CRT)?

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 Implantable pulse generator, pacemaker (non-CRT)?

The FDA product code for Implantable pulse generator, pacemaker (non-CRT) is LWP.

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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