Identity
- Trade Name
- ELASTIMIDE(TM) SILICONE MODIFIED J-LOOP POST. CHAM FDA PMA
Identifiers
- PMA Number
- P900048 FDA PMA
Classification
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Elastimide Silicone Modified J-Loop Post Cham is a silicone-modified intraocular lens (IOL) haptic designed for use in cataract surgery. It features a J-loop configuration with a chamfered edge, intended to enhance stability and positioning within the eye’s capsular bag or sulcus, reducing the risk of postoperative complications such as opacification or dislocation.
This device is supplied sterile and intended for single-use in ophthalmic procedures. Approved under FDA Premarket Approval (PMA P900048), it is manufactured by Staar Surgical Co. and must be handled in accordance with sterile surgical protocols. The J-loop design and silicone modification are key features, with no additional regulatory or safety classifications specified beyond its PMA authorization.
Frequently asked questions
What is the Elastimide Silicone Modified J-Loop Post Cham specifically designed to improve in cataract surgery?
This device is designed to enhance stability and positioning of the intraocular lens (IOL) within the eye’s capsular bag or sulcus. The J-loop configuration with a chamfered edge helps reduce the risk of postoperative complications such as opacification or dislocation, ensuring better long-term placement.
Is the Elastimide Silicone Modified J-Loop Post Cham reusable or intended for single-use, and how should it be handled?
The device is explicitly intended for single-use in ophthalmic procedures. Due to its sterile packaging, it must be handled according to strict sterile surgical protocols to maintain sterility and prevent contamination before and during surgery.
What regulatory pathway was followed for approval of this device, and when was it authorized?
The Elastimide Silicone Modified J-Loop Post Cham was approved through the FDA’s Premarket Approval (PMA) process under PMA number P900048. The decision to approve was made on September 17, 1991, following a review by the Ophthalmic (OP) Advisory Committee.
What key material and design features distinguish this J-loop post from standard IOL haptics?
This device features a silicone-modified J-loop haptic with a chamfered edge, which differentiates it from standard IOL haptics. The silicone modification and chamfered design are intended to improve stability, reduce postoperative complications, and enhance positioning within the eye’s capsular bag or sulcus.
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. Sources consulted: Elastimide (Tm) Silicone Modified J-loop Post. Cham (P900048) — Fda 510 ..., ELASTIMIDE (TM) SILICONE MODIFIED J-LOOP POST. CHAM 510 (k) FDA Approval, Premarket Approval (PMA), fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P900048 | N/A | Active |
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Manufacturer
- Manufacturer
- Staar Surgical Co.
Sources (1)
- FDA PMA P900048 24 fields · synced Sep 18, 2026