4EDTRONIC(R) Hall Prosthetic Heart Valve

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Medtronic(R) Hall Prosthetic Heart Valve

Generic Name

HEART-VALVE, MECHANICAL

PMA Number

P790018 ↗

FDA Product Code

LWQ

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

PMA Supplement

S012

• MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL

  Class II

  FDA 510(k) K241053 Active Cleared 15 May 2024

• Cardiotherm Blood Cardioplegia Systems

  Class II

  FDA 510(k) K960755 Active Cleared 23 May 1996

• Medtronic Overpressure/Vacuum Relief Valve

  Class II

  FDA 510(k) K953564 Active Cleared 2 Feb 1996

• What type of surgical procedure is the Hall Prosthetic Heart Valve intended for, and how is it implanted?

  The Hall Prosthetic Heart Valve is designed specifically for open-heart surgical procedures to replace a diseased or dysfunctional native heart valve. It is implanted during surgery to restore and maintain unidirectional blood flow through the heart, ensuring proper cardiac function. The valve is intended for single-use implantation and must be handled and stored under sterile surgical protocols.

• Is the Hall Prosthetic Heart Valve reusable or single-use, and how should it be stored?

  The Hall Prosthetic Heart Valve is intended for **single-use only** and must not be reused after implantation. Due to its sterile packaging, it should be stored according to standard sterile surgical protocols to maintain integrity until use. Improper storage could compromise sterility and safety.

• What regulatory pathway does the Hall Prosthetic Heart Valve follow, and what does that mean for clinicians?

  The Hall Prosthetic Heart Valve is regulated under the **FDA Premarket Approval (PMA) pathway**, with PMA number **P790018** and product code **LWQ**. This means the device has undergone rigorous review by the FDA to ensure safety and effectiveness before approval. Clinicians can rely on this approval as evidence of the valve’s regulatory compliance for use in cardiac surgery.

• Are there different sizes or models of the Hall Prosthetic Heart Valve, and how would I determine the correct fit for a patient?

  The provided data does not specify exact sizes or models of the Hall Prosthetic Heart Valve, but mechanical heart valves like this typically come in various sizes to accommodate different patient anatomies. Selection should be based on preoperative measurements (e.g., annulus size) and surgical assessment by a cardiothoracic surgeon to ensure proper sizing and function. Always refer to the manufacturer’s surgical guidelines for precise sizing recommendations.