Starr Edwards Silastic Ball Prosthesis Models 1260 & 6120
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESES FDA PMA
- Generic Name
- HEART-VALVE, MECHANICAL FDA PMA
Identifiers
- PMA Number
- P870038 FDA PMA
- FDA Product Code
- LWQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Starr Edwards Silastic Ball Prosthesis Models 1260 & 6120 are mechanical heart valves designed to replace a diseased or dysfunctional aortic or mitral valve. These prostheses employ a silicone elastomer (Silastic) ball occluder within a metallic frame to regulate blood flow through the heart, ensuring unidirectional valve function with minimal turbulence.
These devices are intended for surgical implantation and are supplied sterile for single-use. They are classified as Class III medical devices under FDA regulations and require a Premarket Approval (PMA) application. Models 1260 and 6120 differ in size and are regulated under PMA number P870038, with the latter featuring a slightly larger occluder diameter. Storage and handling must comply with sterile surgical instrument protocols to maintain integrity prior to use.
Frequently asked questions
What types of heart valves can the Starr Edwards Silastic Ball Prosthesis Models 1260 & 6120 replace, and how do the models differ from each other?
The Starr Edwards Silastic Ball Prosthesis Models 1260 and 6120 are designed to replace a diseased or dysfunctional **aortic or mitral valve**. The key difference between the two models lies in their size: Model 6120 features a **slightly larger occluder diameter** compared to Model 1260, allowing it to accommodate different patient anatomies. Both use a silicone elastomer (Silastic) ball within a metallic frame to regulate blood flow unidirectionally.
Are these heart valve prostheses intended for reuse, or are they single-use devices?
The Starr Edwards Silastic Ball Prostheses Models 1260 & 6120 are **sterile, single-use devices**. They are supplied pre-sterilized for surgical implantation and must not be reused to maintain patient safety and device integrity. Sterile handling protocols must be followed as with any surgical implant.
How should these prostheses be stored before use, and what precautions should be taken?
These prostheses must be stored and handled according to **sterile surgical instrument protocols** to preserve their integrity. Since they are single-use and pre-sterilized, they should remain in their original packaging until immediately before implantation. Exposure to moisture, contamination, or physical damage should be avoided, as this could compromise sterility or functionality.
What regulatory pathway was followed for approval of these devices, and how are they classified?
The Starr Edwards Silastic Ball Prostheses Models 1260 & 6120 are **Class III medical devices** under FDA regulations, requiring a **Premarket Approval (PMA)**. They were approved via PMA number **P870038**, with the submission filed in 1987 and finalized in 1991. This classification reflects their role as high-risk, life-sustaining devices intended for permanent implantation.
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 | P870038 | Class III | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA PMA P870038 24 fields · synced Sep 18, 2026