FDA PMA

STENT, SUPERFICIAL FEMORAL ARTERY

PMA Number: P160025 · 2026-09-11

ApplicantBiotronik AG

Decision Date2026-09-11

PMA NumberP160025

Product CodeNIP

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeCV

Device Summary

STENT, SUPERFICIAL FEMORAL ARTERY is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik AG. It received FDA 510(k) clearance on 2026-09-11. The device is classified under product code NIP. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the STENT, SUPERFICIAL FEMORAL ARTERY?

STENT, SUPERFICIAL FEMORAL ARTERY is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Biotronik AG.

When did STENT, SUPERFICIAL FEMORAL ARTERY receive FDA 510(k) clearance?

The clearance date for STENT, SUPERFICIAL FEMORAL ARTERY can be found in the official FDA records.

Who is the listed applicant for STENT, SUPERFICIAL FEMORAL ARTERY?

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

What is the FDA product code for STENT, SUPERFICIAL FEMORAL ARTERY?

The FDA product code for STENT, SUPERFICIAL FEMORAL ARTERY is NIP.

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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.