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FDA 510(k)

LAMITRODE S-SERIES (S4 AND S8) LEADS

K-Number: K022222 · 2002-08-08

ApplicantAdvanced Neuromodulation System,Inc
Decision Date2002-08-08
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LAMITRODE S-SERIES (S4 AND S8) LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Neuromodulation System,Inc. It received FDA 510(k) clearance on 2002-08-08 under 510(k) number K022222. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAMITRODE S-SERIES (S4 AND S8) LEADS?

LAMITRODE S-SERIES (S4 AND S8) LEADS is a medical device that received FDA 510(k) clearance on 2002-08-08. The listed applicant is Advanced Neuromodulation System,Inc. The 510(k) number is K022222.

When did LAMITRODE S-SERIES (S4 AND S8) LEADS receive FDA 510(k) clearance?

LAMITRODE S-SERIES (S4 AND S8) LEADS received FDA 510(k) clearance on 2002-08-08, under 510(k) number K022222.

Who is the listed applicant for LAMITRODE S-SERIES (S4 AND S8) LEADS?

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

What is the FDA product code for LAMITRODE S-SERIES (S4 AND S8) LEADS?

The FDA product code for LAMITRODE S-SERIES (S4 AND S8) LEADS is GZB.

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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.

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