Identity
- Trade Name
- SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE FDA PMA
- Generic Name
- heart-valve, non-allograft tissue FDA PMA
Identifiers
- PMA Number
- P040021 FDA PMA
- FDA Product Code
- LWR FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The SJM Biocor Valve and SJM Biocor Supra Valve are mechanical heart valves designed for surgical implantation in the cardiovascular system. These devices are intended to replace diseased or dysfunctional native heart valves, restoring proper blood flow through the heart’s chambers while maintaining durability and haemodynamic performance over time.
These valves are supplied sterile and intended for single-use in surgical procedures. They are classified as Class III devices under FDA regulations and require surgical implantation by a trained professional. The Biocor Valve and Biocor Supra Valve are authorised under FDA PMA (Premarket Approval) with PMA number P040021, adhering to strict cardiovascular surgical standards for patient safety and efficacy.
Frequently asked questions
What types of heart valves are included in the EPIC VALVE series, and how are they different from each other?
The EPIC VALVE series includes the SJM Biocor Valve and the SJM Biocor Supra Valve, both of which are mechanical heart valves designed for surgical replacement of diseased or dysfunctional native heart valves. While the exact differences between the two are not detailed in the provided data, they are both intended to restore proper blood flow through the heart’s chambers with durability and haemodynamic performance. Both are supplied sterile and intended for single-use in surgical procedures.
Are these valves reusable, or are they meant for single-use only?
The SJM Biocor Valve and SJM Biocor Supra Valve are explicitly stated to be supplied sterile and intended for single-use in surgical procedures. This means they are not designed for reuse and should be discarded after one surgical implantation.
What regulatory pathway was followed for the approval of these heart valves?
The SJM Biocor Valve and SJM Biocor Supra Valve were authorized under the FDA’s Premarket Approval (PMA) pathway, with PMA number P040021. This pathway is typically used for high-risk medical devices like Class III heart valves, ensuring rigorous review and approval for patient safety and efficacy.
What is the intended surgical use for these valves, and who should perform the implantation?
These valves are intended for surgical implantation in the cardiovascular system to replace diseased or dysfunctional native heart valves, restoring proper blood flow. The procedure requires surgical implantation by a trained professional, as mechanical heart valves are not self-inserted or minimally invasive.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P040021 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P040021 24 fields · synced Sep 18, 2026