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FDA 510(k)

MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS

K-Number: K123299 · 2013-01-18

ApplicantSt. Jude Medical Neuromodulation
Decision Date2013-01-18
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical Neuromodulation. It received FDA 510(k) clearance on 2013-01-18 under 510(k) number K123299. 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 MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS?

MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS is a medical device that received FDA 510(k) clearance on 2013-01-18. The listed applicant is St. Jude Medical Neuromodulation. The 510(k) number is K123299.

When did MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS receive FDA 510(k) clearance?

MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS received FDA 510(k) clearance on 2013-01-18, under 510(k) number K123299.

Who is the listed applicant for MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS?

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

What is the FDA product code for MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS?

The FDA product code for MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS is GZB.

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Other records listing St. Jude Medical Neuromodulation as applicant

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Related Devices (Code: GZB)

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

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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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