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FDA PMA

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

PMA Number: P200045 · 2026-06-18

ApplicantBolton Medical, Inc.
Decision Date2026-06-18
PMA NumberP200045
Product CodeMIH
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT is the device name listed in this FDA 510(k) record. The listed applicant is Bolton Medical, Inc.. It received FDA 510(k) clearance on 2026-06-18. The device is classified under product code MIH. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT?

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Bolton Medical, Inc..

When did SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT receive FDA 510(k) clearance?

The clearance date for SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT can be found in the official FDA records.

Who is the listed applicant for SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT?

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

What is the FDA product code for SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT?

The FDA product code for SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT is MIH.

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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