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FDA PMA

Prosthesis, spinous process spacer/plate

PMA Number: P140004 · 2024-11-07

ApplicantBoston Scientific Neuromodulation
Decision Date2024-11-07
PMA NumberP140004
Product CodeNQO
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeOR

Device Summary

Prosthesis, spinous process spacer/plate is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Neuromodulation. It received FDA 510(k) clearance on 2024-11-07. The device is classified under product code NQO. It was reviewed by the OR advisory panel. Product code NQO falls under the category of General Hospital, which covers general-purpose hospital equipment and supplies. Devices in this category are subject to specific FDA regulatory requirements.

Frequently Asked Questions

What is the Prosthesis, spinous process spacer/plate?

Prosthesis, spinous process spacer/plate is a medical device that received FDA 510(k) clearance on 2024-11-07. The listed applicant is Boston Scientific Neuromodulation.

When did Prosthesis, spinous process spacer/plate receive FDA 510(k) clearance?

The clearance date for Prosthesis, spinous process spacer/plate can be found in the official FDA records.

Who is the listed applicant for Prosthesis, spinous process spacer/plate?

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

What is the FDA product code for Prosthesis, spinous process spacer/plate?

The FDA product code for Prosthesis, spinous process spacer/plate is NQO. This falls under the General Hospital category.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

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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