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FDA PMA

System, laser, fiber optic, photodynamic therapy

PMA Number: P940010 · 2021-02-24

ApplicantPinnacle Biologics, Inc.
Decision Date2021-02-24
PMA NumberP940010
Product CodeMVG
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeSU

Device Summary

System, laser, fiber optic, photodynamic therapy is the device name listed in this FDA 510(k) record. The listed applicant is Pinnacle Biologics, Inc.. It received FDA 510(k) clearance on 2021-02-24. The device is classified under product code MVG. It was reviewed by the SU advisory panel.

Frequently Asked Questions

What is the System, laser, fiber optic, photodynamic therapy?

System, laser, fiber optic, photodynamic therapy is a medical device that received FDA 510(k) clearance on 2021-02-24. The listed applicant is Pinnacle Biologics, Inc..

When did System, laser, fiber optic, photodynamic therapy receive FDA 510(k) clearance?

The clearance date for System, laser, fiber optic, photodynamic therapy can be found in the official FDA records.

Who is the listed applicant for System, laser, fiber optic, photodynamic therapy?

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

What is the FDA product code for System, laser, fiber optic, photodynamic therapy?

The FDA product code for System, laser, fiber optic, photodynamic therapy is MVG.

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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