FDA 510(k)

Patient Assistant Model PA97000

K-Number: K190574 · 2019-09-24

Decision Date2019-09-24

Product CodeDSI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Patient Assistant Model PA97000 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2019-09-24 under 510(k) number K190574. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient Assistant Model PA97000?

Patient Assistant Model PA97000 is a medical device that received FDA 510(k) clearance on 2019-09-24. The listed applicant is Medtronic, Inc.. The 510(k) number is K190574.

When did Patient Assistant Model PA97000 receive FDA 510(k) clearance?

Patient Assistant Model PA97000 received FDA 510(k) clearance on 2019-09-24, under 510(k) number K190574.

Who is the listed applicant for Patient Assistant Model PA97000?

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

What is the FDA product code for Patient Assistant Model PA97000?

The FDA product code for Patient Assistant Model PA97000 is DSI.

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.

NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITING NCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATION

Other records listing Medtronic, Inc. as applicant

PMA P960009Stimulator, electrical, implanted, for parkinsonian tremor PMA P860004Pump, infusion, implanted, programmable PMA P130021Aortic valve, prosthesis, percutaneously delivered PMA P240013Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation PMA P100047Ventricular (assist) bypass PMA P980035Pulse generator, permanent, implantable

View all 166 devices →

Related Devices (Code: DSI)

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SA K193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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.