Lincoff-Design Scleral Buckling Balloon Catheter
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER FDA PMA
- Generic Name
- Catheter, balloon for retinal reattachment FDA PMA
Identifiers
- PMA Number
- P820009 FDA PMA
- FDA Product Code
- LOG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APWD FDA PMA
The Lincoff-Design Scleral Buckling Balloon Catheter is a catheter with a balloon used for retinal reattachment procedures. It is designed to assist in the surgical treatment of retinal detachment by providing controlled buckling of the sclera.
This device is supplied as a single-use or reusable product depending on the specific model and is intended for ophthalmic surgical procedures. It is authorized under FDA PMA and available in various sizes as specified by the manufacturer.
Frequently asked questions
What is the primary purpose of the Lincoff-Design Scleral Buckling Balloon Catheter in retinal surgery?
The Lincoff-Design Scleral Buckling Balloon Catheter is specifically designed to assist in retinal reattachment procedures by enabling controlled buckling of the sclera. This helps to physically reposition the retina against the eye wall, aiding in the surgical treatment of retinal detachment.
Is this device single-use or reusable, and how should I determine which model I need?
The Lincoff-Design Scleral Buckling Balloon Catheter is available in both single-use and reusable configurations, depending on the specific model. To determine which model suits your needs, consult the manufacturer’s documentation or contact Bausch and Lomb directly, as they provide details on usage restrictions and sterilization guidelines for each variant.
What sizes are available for the Lincoff-Design Scleral Buckling Balloon Catheter, and how do I select the right one?
The device comes in various sizes as specified by Bausch and Lomb, though exact measurements are not provided in the data. Selection should be based on the patient’s anatomy and the surgeon’s preference for the procedure. For precise sizing guidance, refer to the manufacturer’s product catalog or surgical planning resources.
How was this device authorized for use in the United States, and what regulatory pathway was followed?
The Lincoff-Design Scleral Buckling Balloon Catheter was authorized through the FDA’s Premarket Approval (PMA) process, indicated by the PMA number **P820009**. This pathway is typically used for high-risk medical devices like Class III products, ensuring rigorous review by the FDA before market clearance.
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 | P820009 | Class III | Active |
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Manufacturer
- Manufacturer
- Bausch and Lomb
- FDA Applicant
- Bausch & Lomb
Sources (1)
- FDA PMA P820009 24 fields · synced Oct 6, 2026