FDA 510(k)

TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS

K-Number: K063080 · 2006-12-12

ApplicantAdvanced Neuromodulation Systems

Decision Date2006-12-12

Product CodeGZB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Neuromodulation Systems. It received FDA 510(k) clearance on 2006-12-12 under 510(k) number K063080. 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 TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS?

TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS is a medical device that received FDA 510(k) clearance on 2006-12-12. The listed applicant is Advanced Neuromodulation Systems. The 510(k) number is K063080.

When did TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS receive FDA 510(k) clearance?

TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS received FDA 510(k) clearance on 2006-12-12, under 510(k) number K063080.

Who is the listed applicant for TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS?

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

What is the FDA product code for TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS?

The FDA product code for TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES 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.